System and method for an orthopedic dynamic data repository and registry for recall

ABSTRACT

At least one embodiment is directed to a system ( 1100 ) to generate an orthopedic dynamic data repository and registry ( 2214 ). The system ( 1100 ) can measure a parameter of the muscular-skeletal system and align at least one of the surfaces to a mechanical axis intra-operatively. The system ( 1100 ) comprises disposable sensors ( 1106 ), disposable targets ( 1110 ), lasers ( 1114 ), a processing unit ( 1122 ), a display ( 1124 ), a reader ( 1120 ), a receiver ( 1118 ), spacer blocks ( 1102 ), and a distractor  1104 . The sensors ( 1106 ) are in communication with the processing unit ( 1122 ) to display, process, store, and send data to dynamic data repository and registry ( 2214 ). Parameters can be measured pre-operatively, intra-operatively, post-operatively, and long term using sensor ( 1106 ). The measurement data is used to identify and provide clinical evidence of a health risk. A notification of the health risk is generated in electronic digital form and sent to at least one entity.

CROSS-REFERENCE

This application claims the priority benefits of U.S. Provisional Patent Application No. 61/211,023 filed on Mar. 26, 2009, the entire contents of which are hereby incorporated by reference. This application further claims the priority benefits of U.S. provisional patent application Nos. 61/221,761, 61/221,767, 61/221,779, 61/221,788, 61/221,793, 61/221,801, 61/221,808, 61/221,817, 61/221,867, 61/221,874, 61/221,879, 61/221,881, 61/221,886, 61/221,889, 61/221,894, 61/221,901, 61/221,909, 61/221,916, 61/221,923, and 61/221,929 all filed 30 Jun. 2009. The disclosures of which are incorporated herein by reference in its entirety.

FIELD

The disclosure relates in general to orthopedics, and particularly though not exclusively, is related to a dynamic data repository and registry and a method for collecting and accessing the quantitative measurements.

BACKGROUND

The skeletal system is a balanced support framework subject to variation and degradation. Changes in the skeletal system can occur due to environmental factors, degeneration, and aging. An orthopedic joint of the skeletal system typically comprises two or more bones that move in relation to one another. Movement is enabled by muscle tissue and tendons attached to the skeletal system of the joint. Ligaments hold and stabilize the one or more joint bones positionally. Cartilage is a wear surface that prevents bone-to-bone contact, distributes load, and lowers friction. The spinal column is comprised of vertebrae, discs, ligaments, and muscles that stabilize the vertebral column and protects the spinal nerves.

There has been substantial growth in the repairing of the human skeletal system as orthopedic joint implant technology has evolved. In general, improvements to orthopedic implant joints have been based on empirical data that is sporadically gathered from real patients. Similarly, the majority of implant surgeries are being performed with tools that have not changed substantially in decades but have been refined over time. In general, the orthopedic implant procedure has been standardized to meet the needs of the general population. Adjustments due to individual skeletal variations rely on the skill of the surgeon to adjust the process for the exact circumstance. At issue is that there is little or no data during an orthopedic surgery, post-operatively, and long term that provides feedback to the orthopedic manufacturers and surgeons about the implant status.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments will become more fully understood from the detailed description and the accompanying drawings, wherein:

FIG. 1 is a top view of a dynamic distractor in accordance with an exemplary embodiment;

FIG. 2 is a side view of a dynamic distractor having a minimum height in accordance with an exemplary embodiment;

FIG. 3 is a view of a dynamic distractor opened for distracting two surfaces from each other in accordance with an exemplary embodiment;

FIG. 4 is an anterior view of a dynamic distractor placed in a knee joint in accordance with an exemplary embodiment;

FIG. 5 is a lateral view of dynamic distractor in a knee joint positioned in flexion in accordance with an exemplary embodiment;

FIG. 6 is a lateral view of a dynamic distractor in a knee joint coupled to a cutting block in accordance with an exemplary embodiment;

FIG. 7 is an anterior view of a cutting block coupled to dynamic distractor in accordance with an exemplary embodiment;

FIG. 8 is an illustration of dynamic distractor including alignment in accordance with an exemplary embodiment;

FIG. 9 is a side view of a leg in extension with a dynamic distractor in the knee joint region in accordance with an exemplary embodiment;

FIG. 10 is a top view of a leg in extension with a dynamic distractor in the knee joint area in accordance with an exemplary embodiment;

FIG. 11 is an illustration of a system for measuring one or more parameters of a biological life form in accordance with an exemplary embodiment;

FIG. 12 depicts an exemplary diagrammatic representation of a machine in the form of a computer system within which a set of instructions, when executed, may cause the machine to perform any one or more of the methodologies discussed above;

FIG. 13 is an illustration of a communication network for measurement and reporting in accordance with an exemplary embodiment;

FIG. 14 is an exemplary method for distracting surfaces of the muscular-skeletal system in accordance with an exemplary embodiment;

FIG. 15 is an exemplary method for distracting surfaces of the muscular-skeletal system in extension and in flexion in accordance with an exemplary embodiment;

FIG. 16 is an exemplary method for distracting surfaces of the muscular-skeletal system in extension and in flexion in accordance with an exemplary embodiment;

FIG. 17 is an exemplary method for distracting surfaces of a knee joint in extension and in flexion in accordance with an exemplary embodiment;

FIG. 18 is an exemplary method to place the muscular-skeletal system in a fixed position for bone shaping in accordance with an exemplary embodiment;

FIG. 19 is an exemplary method of measuring the muscular-skeletal system in accordance with an exemplary embodiment;

FIG. 20 is an exemplary method of a disposable orthopedic system in accordance with an exemplary embodiment;

FIG. 21 is an exemplary method of a disposable orthopedic system in accordance with an exemplary embodiment;

FIG. 22 is a diagram illustrating a data repository and registry for evidence based orthopedics in accordance with at least one exemplary embodiment;

FIG. 23 is a diagram illustrating an orthopedic lifecycle approach to manage orthopedic health based on patient clinical evidence in accordance with at least one exemplary embodiment.

FIG. 24 is a diagram illustrating a customer selection of data from a data repository and registry in accordance with an exemplary embodiment;

FIG. 25 is a diagram illustrating intra-operative measurement of a parameter of the muscular-skeletal system in accordance with an exemplary embodiment;

FIG. 26 is a diagram illustrating one or more predetermined ranges to perform an orthopedic procedure in accordance with an exemplary embodiment;

FIG. 27 is a diagram illustrating health risk identification and notification an orthopedic device, procedure, or medicine in accordance with an exemplary embodiment; and

FIG. 28 is a diagram illustrating an analysis of the efficacy of an orthopedic device, procedure, or medicine in accordance with an exemplary embodiment.

DETAILED DESCRIPTION

The following description of exemplary embodiment(s) is merely illustrative in nature and is in no way intended to limit the invention, its application, or uses.

Processes, techniques, apparatus, and materials as known by one of ordinary skill in the art may not be discussed in detail but are intended to be part of the enabling description where appropriate. For example specific computer code may not be listed for achieving each of the steps discussed, however one of ordinary skill would be able, without undo experimentation, to write such code given the enabling disclosure herein. Such code is intended to fall within the scope of at least one exemplary embodiment.

Additionally, the sizes of structures used in exemplary embodiments are not limited by any discussion herein (e.g., the sizes of structures can be macro (centimeter, meter, and size), micro (micrometer), nanometer size and smaller).

Notice that similar reference numerals and letters refer to similar items in the following figures, and thus once an item is defined in one figure, it may not be discussed or further defined in the following figures.

In all of the examples illustrated and discussed herein, any specific values, should be interpreted to be illustrative only and non-limiting. Thus, other examples of the exemplary embodiments could have different values.

In general, successful orthopedic surgery including the implantation of an orthopedic device into the muscular-skeletal system depends on multiple factors. One factor is that the surgeon strives to maintain adequate alignment of the extremity or implanted device to the ideal. A second factor is proper seating of an implant for stability. A third factor is loading on the skeletal system or replacement implant. A fourth factor is alignment of implanted components in relation to one another. A fifth factor is balance of loading over a range motion.

By way of a device herein contemplated, the surgeon receives measured data during surgery and post operatively on the factors listed above. As one example, accurate measurements can be made during orthopedic surgery to determine if bones or an implant are optimally balanced and aligned. This can reduce operating time and surgical stress for both the surgeon and patient. The data generated by direct measurement can be further processed to assess long-term integrity based on maintaining surgical parameters within predetermined ranges. The measured data in conjunction with patient information can lead to improved design and materials.

FIG. 1 is a top view of a dynamic distractor 100 in accordance with an exemplary embodiment. Dynamic distractor 100 is also known as a dynamic spacer block. Dynamic distractor 100 is a sensored device that is used during surgery of a muscular-skeletal system. Dynamic distractor 100 can be used in conjunction with other tools common to orthopedic surgery as will be disclosed in more detail hereinbelow. In at least one exemplary embodiment, the system is used during orthopedic joint surgery and more specifically during implantation of an artificial joint. The system uses one or more sensors intra-operatively to define implant loading, positioning, achieve appropriate implant orientation, balance, and limb alignment. In particular, dynamic distractor combines the ability to align and measure one or more other parameters (e.g. load, blood flow, distance, etc. . . . ) that provides quantitative data to a surgeon that allows the orthopedic surgery to be measured and adjusted within predetermined values or ranges based on the measured data and a database of other similar procedures. The system is designed broadly for use on the skeletal system including but not limited to the spinal column, knee, hip, ankle, shoulder, wrist, articulating, and non-articulating structures.

Dynamic distractor 100 comprises an upper support structure and a lower support structure. An active or dynamic spacer portion 120 of dynamic spacer block comprises the upper and lower support structures. A lift mechanism (not shown) couples to an interior surface of upper support structure and an interior surface of the lower support structure. A handle 112 couples to the lift mechanism. In one embodiment, handle 112 is operatively coupled to the lift mechanism to change a gap of the spacer block. Handle 112 can also be used to guide dynamic distractor 100 between regions of the muscular-skeletal system. In general, the upper support structure has a superior surface 102 that interfaces with a surface of the muscular-skeletal system. Similarly, the lower support structure has an inferior surface that interfaces with a surface of the muscular-skeletal system.

In one embodiment, handle 112 can be rotated to adjust the lift mechanism to increase or decrease a gap between the superior and inferior surfaces of the active spacer block thereby modifying the height or thickness of dynamic distractor 100. In a non-limiting example to illustrate a disposable aspect, superior surface 102, the inferior surface, or both surfaces include at least one cavity or recess for housing at least one sensor module. The sensor module includes at least one sensor for measuring a parameter of the muscular-skeletal system. For example, the sensor can measure a force or pressure. As will be disclosed hereinbelow, the sensor can be disabled so it cannot be reused and disposed of after the procedure has been performed. In a further example, dynamic distractor 100 can be placed between two or more bone surfaces such that the superior surface 102 and the inferior surface contact surfaces of the muscular-skeletal system related to a joint. In one embodiment, the sensor is coupled to a surface of the muscular-skeletal system for measuring a parameter when positioned between surfaces. Handle 112 can be rotated to different gap heights allowing pressure measurements at the different gap heights to generate data of gap versus pressure.

Handle 112 further includes an opening 114, a decoupling mechanism 118, and a display 116. Opening 114 is used to receive additional components of the system that will be described in more detail hereinbelow. Decoupling mechanism 118 allows removal of the handle during parts of a surgery to allow access to the muscular-skeletal system. Decoupling mechanism 118 couples to a locking mechanism that locks handle 112 to a shaft of the lift mechanism. Decoupling mechanism 118 releases the locking mechanism thereby allowing handle 112 to be removed from dynamic distractor 100. In one embodiment, the locking mechanism is a pin or ball that fits into a corresponding feature 122 on the shaft of the lift mechanism. Decoupling mechanism 118 releases or frees the pin or ball from feature 1122 thereby allowing removal of handle 112. Alternatively, decoupling mechanism 118 can be a hinge or joint that allows handle 112 to move in a direction that allows greater access by the surgeon to an area where the spacer block portion of dynamic distractor 100 has been placed. The display 116 on handle 112 can provide a readout of the gap between the superior surface 102 and the inferior surface as handle 112 is rotated to adjust spacing.

In a non-limiting example, dynamic distractor 100 is adapted for use in artificial knee implant surgery. It should be noted that dynamic distractor 100 can be similarly adapted for other orthopedic surgery where both distraction and parameter measurement is beneficial. A knee implant is used merely as an example to illustrate how dynamic distractor 100 can be used in a surgical environment. In at least one exemplary embodiment, the superior surface 102 of dynamic distractor 100 includes a recess or cavity 104 and a second recess or cavity 106. In one embodiment, a sensor 108 and a sensor 110 are pre-sterilized in one or more packages. The packaging is opened prior to or during surgery within the surgical zone to maintain sterility. Sensors 108 and sensor 110 are shown respectively placed in cavities 104 and 106 for measuring a parameter that aids in the surgical procedure. In the knee example, sensors 108 and 110 include pressure sensors such as strain gauges, mechanical-electrical-machined (mems) sensors, diaphragm structures, mechanical sensors, or other pressure measuring devices. In one embodiment, a major exposed surface of sensors 108 and 110 is in contact with the muscular-skeletal system after insertion. Alternatively, one or more layers of material or portions of the muscular-skeletal system can be between sensors 108 and 110 such that the parameter can be measured or transferred through the intervening layers. A force or pressure applied to the exposed surfaces is measured by sensors 108 and 110 while the gap of the dynamic distractor is adjusted. Alternatively, the lift mechanism in conjunction with sensors 108 and 110 can be set to a predetermined pressure. The lift mechanism gap will increase until the predetermine pressure is reached. Thus, identifying a gap height or thickness of dynamic distractor 100 to achieve the predetermined pressure.

In at least one exemplary embodiment, sensors 108 and 110 are disposable devices. After measurements have been taken, sensors 108 and 110 can be removed and disposed of in an appropriate manner. Alternatively, the sensors 108 and 110 can be permanent or an integral part of the superior surface of dynamic distractor 100. The housing can be designed to be reused and to withstand a sterilization process after each use. The main body of dynamic distractor 100 as well as sensors 108 and 110 are cleaned and sterilized before each surgical usage.

Dynamic distractor 100 in a zero gap (or closed condition) is less than 8 millimeters thick for the knee application and can expand using the lift mechanism to greater than 25 millimeters. This range is sufficient for the majority of artificial knee implant surgeries being performed. The spacer portion 120 of dynamic distractor 100 contains the superior surface 102 and the inferior surface that articulates to at least two bone ends of the muscular-skeletal system. In the knee example, the dynamic distractor 100 is placed between the distal end of the femur and the proximal end of the tibia. As mentioned previously sensors 108 and 110 are in a housing. In one embodiment, the housing includes sensor elements to define the loads on the medial and lateral compartments. The sensored elements can comprise load displacement sensors, accelerometers, GPS locators, telemetry, power management circuitry, a power source and an ASIC.

As disclosed above, the spacer portion 120 of dynamic distractor 100 is placed between the femur and tibia in extension. The dynamic distractor 100 is configured with no gap (e.g. minimum height or thickness) or having a gap that can be inserted and removed without tissue damage. In general, the gap can be increased by rotating handle 112 after insertion such that the inferior surface of dynamic distractor 100 contacts a prepared surface of a proximal end of a tibia and the superior surface contacts the prepared distal end of the femur. In general, the femoral and tibial cuts in extension are made parallel to one another. Similarly, the femoral cut in flexion is made parallel to the prepared end of the tibia. The gap is measured to determine a combined thickness of the implants with the leg in extension. The prepared ends of the tibia and femur can be checked for alignment with the mechanical axis at this time as will be disclosed in detail below.

Typically, the surgeon selects the artificial components based on the cross-sectional size of the prepared bones. The variable component of the implant surgery is the final insert. The final insert has one or more bearing surfaces for interfacing with a femoral implant. In one embodiment, the measured gap height created by dynamic distractor 100 is used to define an insert thickness or height. The thickness of a final insert can change during surgery as further bone cuts or tissue tensioning occurs. Dynamic distractor 100 can be used during surgery to measure loading and gap height after each bone modification or after an orthopedic component has been implanted.

Dynamic distractor 100 can also be used to obtain an optimal balance. Balance is related to the measured loading between two or more areas. The measured values can than be adjusted to a predetermined relationship and within a predetermined value range. In the knee example, balance is associated with the differential pressure applied by each condyle on the bearing surfaces of the implant. Ideally, a predetermined surface area of the femoral implant condyle contacts the bearing surface to distribute the load and minimize wear. In a non-limiting example, a predetermined relationship between measured values by sensors 108 and 110 of dynamic distractor 100 is maintained after implantation of the artificial components. In one embodiment, the balance of the knee is maintained by having the measured load in each compartment approximately equal. A method to balance the loading of the compartments is through ligament release on the side having the larger loading value. Ligament release reduces loading primarily on the adjacent compartment. The loading can be read off a display on dynamic distractor 100 allowing the surgeon to view the change in loading and the differential value with each release. The lift mechanism provides sufficient room between the superior and inferior surfaces of dynamic distractor 100 for a surgeon to perform a release procedure without removing the device. A next greater thickness of an insert can be selected should the absolute loading value on each condyle fall outside the predetermined range due to the soft tissue release. Handle 112 can be rotated to increase the gap height to the next larger insert value to ensure the measured loading falls within the predetermined range and the differential loading falls within a predetermined range (after the soft tissue release).

The loading and balance of an implanted joint should be maintained within the predetermined values throughout the range of motion. In at least one exemplary embodiment, measurements are taken when the tibia is at a ninety-degree angle to the femur. Handle 112 is used to position the spacer block portion of distractor 100 between the femur and the tibia. The inferior surface of dynamic distractor 100 is in contact with the prepared surface of the tibia. In one embodiment, the superior surface 102 is in contact with the remaining portion of the condyles of the femur. Thus, the condyle surfaces of the femur are in contact with sensors 108 and 110 on the superior surface of dynamic distractor 100. In the example, a gap height of dynamic distractor 100 is reduced to accommodate the condyles that remain on the distal end of the femur in flexion. The gap height of dynamic distractor 100 can then be adjusted to a height corresponding to the gap height in extension less the thickness of the femoral implant whereby the leg in flexion is similar to the leg in extension.

The loading on sensors 108 and 110 with the leg in flexion can be measured. The measurement is of value if the condyles are not damaged or degraded. In one embodiment, soft tissue release is used to adjust the balance between compartments with the leg in flexion. The soft tissue release can also be performed later in the procedure after the femoral implant has been implanted. Similar to the leg in extension, soft tissue release is performed to reduce the tension on the side having the higher compartment reading with dynamic distractor 100 in place. After soft tissue release, the readings in each compartment should be within a predetermined differential range. The distal end of the femur can then be prepared for receiving the femoral implant, which removes the remaining portion of the condyles. As disclosed, the surface of the femur is prepared to be parallel to the prepared tibial surface in flexion. This can be achieved by specific ligament releases in flexion, and/or rotation of the femoral implant to achieve parallel levels between the posterior femoral condyles and proximal tibia. A femoral sizer can be attached to the distractor to allow sizing of the femur coupled with rotation of the femur. This allows dynamic rotation to obtain equally balanced flexion compartments.

In a non-limiting example, the femoral implant component can be temporarily attached to the distal end of the femur. Measurements can be taken throughout the entire three-dimensional range of motion using dynamic distractor 100 to ensure that the implanted knee operates similarly in all positions. A gap provided by dynamic distractor 100 would be adjusted to a combined thickness of the final insert thickness and the tibial implant thickness. Dynamic distractor 100 can incrementally increase or decrease the gap to allow the surgeon to determine how different insert thicknesses affect load and balance measurements. In one embodiment, accelerometers are used to provide position and relational positioning information. The data can be stored in memory for later use or displayed to provide instant feedback to the surgeon on the implant status. Further adjustments to load and balance can be made with dynamic distractor in place if desired over different positions within the range of motion. Although one implant sequence is disclosed, it is well known that surgeons have different approaches, methodologies and procedure sequences. The use of dynamic distractor 100 would be applied similarly to distract and measure in different relational positions with the device in place. Furthermore, the device can be used or modified for use on different parts of the anatomy of the muscular-skeletal system.

FIG. 2 is a side view of dynamic distractor 100 having a minimum height in accordance with an exemplary embodiment. Dynamic distractor comprises an upper support structure 202 having superior surface 102 and a lower support structure 204 having an inferior surface 206. In the example, upper support structure 202, the lift mechanism, and lower support structure 204 supports loading typical for a joint of the muscular-skeletal system. Upper and lower support structures 202 and 204 comprise a rigid and load bearing materials such as metals, composite materials, and plastics that will not flex under loading. In one embodiment, stainless steel is used in the manufacture of the lift mechanism and upper and lower support structures 204 and 202.

Dynamic distractor 100 is used to distract surfaces of the muscular-skeletal system. Dynamic distractor 100 can be used in an invasive procedure such as orthopedic surgery. In the non-limiting example, dynamic distractor 100 can distract surfaces of the muscular-skeletal system in a range of approximately 8 millimeters to 25 millimeters. The support surfaces of dynamic distractor 100 do not flex under loading of the muscular-skeletal system. In one embodiment, dynamic distractor 100 has a minimum height or thickness between support surfaces of less than 8 millimeters. In at least one application, a space between support structures 202 and 204 is provided when dynamic distractor 100 is opened to a height greater than the minimum height. The space between support structures 202 and 204 when opened allows a surgeon to perform soft tissue release with the device in place.

A cavity 104 is illustrated in superior surface 102 of upper support structure 202. The cavity 104 is shaped similarly to a housing 210 of sensor 108. Housing 210 is placed within cavity 108 for measuring a compressive force applied across superior surface 102 and inferior surface 206. In the knee example, a condyle (implanted or natural) couples to an exposed surface of sensor 108. A pressure or force applied to sensor 108 is measured and displayed by dynamic distractor 100. Sensor 110 is shown placed in its corresponding cavity in superior surface 102. In one embodiment, the exposed surfaces of sensors 108 and 110 are approximately planar to the superior surface 102. The exposed surface of sensor 108 and 110 can be flat or contoured. Sensors 108 and 110 can be removed from upper support structure 202 and disposed after the surgery has been performed. In one embodiment, a push rod is exposed in the interior surface of upper support structure 202 that when pressed can apply a force to housing 210 that removes sensor 108 from cavity 208

In one embodiment, housing 210 is formed of a plastic material. The sensor and electronic circuitry is fitted in housing 210. The electronic circuitry comprises one or more sensors 220, one or more accelerometers 222, an ASIC integrated circuit 224, a power source 226, power management circuitry 228, GPS circuitry 230, and telemetry 232. The power source 226 can be a battery or other temporary power source that is coupled to the electronic circuitry prior to surgery. The power source 226 has sufficient power to enable the circuitry for a period of time that will cover the vast majority of surgeries. The power management circuitry 228 works in conjunction with the power source to maximize the life of the power source by disabling system components when they are not being used. In general, an ASIC circuit controls and coordinates when sensing occurs, can store data to memory, and can transmit data in real time or collect and send data at a more appropriate time to a remote system for further processing. The ASIC includes multiple ports that couple to one or more sensors 220. The ASIC couples, to at least one sensor 220, at least one accelerometer 222, GPS 232, and telemetry circuitry 232. The ASIC 222 can include the integration of telemetry circuitry 232, power management circuitry 228, GPS circuitry 230, memory, and sensors 220 to further reduce the form factor of the sensing system. In the example, the at least one sensor 220 is a pressure sensor that is coupled to the exposed surface of the housing. The pressure sensor converts the pressure to an electrical signal that is received by the ASIC. The at least one accelerometer 222 and GPS 232 provides positioning information at the time of sensing. Telemetry circuitry 232 communicates through a wired or wireless path. In one embodiment, the data is sent to a remote processing unit that can process and display information for use by the surgeon or medical staff. One or more displays 234 can be placed on dynamic distractor 100 to simplify viewing of a pressure or force measured by sensors 108 and 110 thereby allowing real time loading and balance differential to be seen at a glance. The information can be stored in memory on the sensor or transmitted to a database for long-term storage and processing.

In a zero gap or minimum height condition, the lift mechanism is enclosed within the device. An opening 212 exposes a threaded rod 216 that is a component of the lift mechanism. The exposed end portion of threaded rod 216 is shaped for receiving handle 112. For example, a proximal end 214 of handle 212 is shown having a hexagonal opening that operatively couples to a hexagonal shaped end of threaded rod 216. The surfaces of the hexagonal surface mate with the surfaces of the threaded rod for distributing the torque required to rotate threaded rod 216 when increasing a gap between superior surface 102 and inferior surface 206 to distract surfaces of the muscular-skeletal system. Distributing the torque over a large surface area prevents stripping of either the hexagonal shaped opening of handle 212 or the hexagonal shaped exposed end of threaded rod 216 when the device is under load. In one embodiment, a release and locking mechanism fastens handle 112 to threaded rod 216. Pressing or sliding unlocking button 218 releases the locking mechanism to allow removal of handle 112.

FIG. 3 is a view of dynamic distractor 100 opened for distracting two surfaces of the muscular-skeletal system in accordance with an exemplary embodiment. A lift mechanism 302 comprises a scissor mechanism 304 for raising and lowering upper support structure 202 and lower support structure 204. In one embodiment, scissor mechanism 304 comprises more than one support structure each having a pivot. Scissor mechanism 304 is operatively coupled to an interior surface of upper support structure 202 and an interior surface of lower support structure 204. The structural beams are pinned to allow pivoting around the axis of attachment. The remaining beam-ends rest on the interior surfaces of either the upper and lower support structures 202 and 204. The beam-ends not fastened to the interior surfaces support upper and lower support structures 202 and 204 under load. Threaded rod 212 is operatively coupled between the beam-ends of scissor mechanism 304 corresponding to lower support structure 204. Rotating rod 212 can increase or decrease distance between beam ends of the scissor mechanism 204.

A rod 306 can be coupled to opening 114 of handle 112. The rod 306 can be used to reduce the torque needed to rotate threaded rod 212 in either direction under load. Increasing a distance between beam-ends of scissor mechanism 304 reduces the gap between superior surface 102 and inferior surface 206 as the two or more beams pivot around a centrally located axis. Conversely, decreasing a distance between beam-ends of scissor mechanism 304 increases the gap between superior surface 102 and inferior surface 206.

FIG. 4 is an anterior view of a dynamic distractor 100 placed in a knee joint in accordance with an exemplary embodiment. In the non-limiting example, a distal end of a femur 102 is shown having a femoral implant. The femoral implant has artificial condyles that contact sensors 108 and 110. The proximal end of a tibia 404 has been initially shaped for receiving a tibial implant. As is well known by one skilled in the art, a complete knee implant comprises the tibial implant, the femoral implant, and an insert that includes bearing surfaces that mate with the artificial condyle surfaces of the femoral implant. In one embodiment, dynamic distractor (100) includes an adjustable handle 112 that aids in the insertion of the spacer portion into a joint region of the muscular-skeletal system. For example, the spacer portion of dynamic distractor 100 is inserted into the knee joint using handle 112 but then rotated away from the patellar tendon, collapsed into the trail, or removed to allow the reduction of the patella to depict loads on the instrument. The thickness or height of the three components is contemplated for the bone surface preparation when using dynamic distractor 100. In one embodiment, the combined thickness of the femoral implant, final insert, and tibial implant is approximately 20 millimeters thick. Adjustments to the prepared bone surfaces and thickness of the insert are made during surgery using data provided by dynamic distractor 100 to ensure correct loading, balance, and alignment.

Sensors 108 and 110 include circuitry for communication with a processing unit 406. In one embodiment, data is sent wirelessly using a radio frequency communication standard such as Bluetooth, UWB, or Zigbee. The data can be encrypted to securely transmit the patient information and maintain patient privacy. In one embodiment, external processing unit 406 is in a notebook computer, personal computer, or custom equipment. For illustration purposes, external processing unit 406 is shown in a notebook computer that includes software and a GUI designed for the surgical application. The notebook computer has a display 408 that can be used by the medical staff during the operation to display real time measurement from dynamic distractor 100. The notebook computer is typically placed outside the surgical zone but within viewing range of the surgeon.

A substantial benefit of dynamic distractor 100 is in performing soft tissue release both in extension and in flexion. In extension, dynamic distractor 100 can be set to a height corresponding to an insert size. In one embodiment, manufacturers of an implantable joint will provide specifications for load, balance, and alignment once sufficient clinical data has been generated. The surgeon can also manipulate the leg to subjectively gauge the loading on the joint. The surgeon can adjust dynamic distractor 100 to increase or decrease the height or gap corresponding to a different thickness insert size until a desired loading is achieved. A substantial imbalance corresponds to a differential loading measured by sensors 108 and 110 outside a predetermined range. The loading measured by sensors 108 and 110 should be approximately equal in each compartment. The data provided by sensors 108 and 110 can be used to provide a solution to the surgeon. For example, data from sensors 108 and 110 is sent wirelessly to processing unit 406. The data indicates a substantial differential pressure between measurements from sensors 108 and 110 (e.g. imbalance). In one embodiment, the data can be processed and displayed on display 408 with suggestions for the removal of material from the tibial surface to reduce the differential reading. The suggestion can include where material should be removed and how much material is removed from the tibial surface. Alternatively, the assessment of the loading and differential between compartments can indicate that soft tissue release is sufficient to bring the joint within predetermined ranges for absolute load and balance.

A further benefit of dynamic distractor 100 is in soft tissue release to modify loading measured by sensors 108 and 110 and the differential (e.g. balance) between the measured values in each compartment. Dynamic distractor 100 remains in place while soft tissue release is being performed allowing for real time measurement and modification to occur. The feedback to the surgeon is immediate as the soft tissue cuts are made. Two issues are resolved by dynamic distractor 100. An open area formed between the interior surfaces of upper support structure 202 and lower support structure 204 under distraction provides surgical access. In most cases, the gap is sufficient to allow a scalpel or blade access to the lateral or medial ligaments for soft tissue release in the gap or peripheral to dynamic distractor 100. In general, soft tissue release requires anterior access to the joint space. Handle 112 of dynamic distractor 100 can be removed providing further anterior access to the joint. Alternatively, handle 112 is hinged or includes a joint allowing it to be positioned away from the surgical area. Thus, dynamic distractor 100 enables soft tissue release by the surgeon to adjust the absolute loading measured by sensors 108 and 110 in each compartment to be within a predetermined range and to adjust the difference in compartment loadings within a predetermined range without removing the device.

FIG. 5 is a lateral view of dynamic distractor 100 in a knee joint positioned in flexion in accordance with an exemplary embodiment. In a non-limiting example, load and balance measurements are performed using dynamic distractor 100 with the leg in at least two positions (e.g. the leg in extension and the leg in flexion). For example, measurements are taken in extension as disclosed hereinabove and in flexion with the leg positioned having femur 402 forming a 90 degree angle to tibia 404. In one embodiment, accelerometers in sensors 108 and 110 are used to determine relative positioning of the femur and tibia to one another. Under user control, measurements are taken at several points over the range of motion with dynamic distractor 100 in place thereby substantially simplifying a data collection process. Measurements over the range of motion can be taken when the femoral implant has been installed or if the distal femur has not been modified. Alternatively, dynamic distractor 100 can be reduced in height by rotating handle 112 until there is sufficient room to move the leg to a new position and then increasing the height of distractor 100 to create the appropriate gap.

A drop alignment rod 502 is placed through opening 114 of handle 112. Drop alignment rod 502 is a visual aid for the surgeon to ensure that the leg is aligned adequately when the load and balance measurements are taken. Drop alignment rod 502 is used in conjunction with a knowledge of the leg mechanical axis or with markers placed on the patient to check alignment. The surgeon aligns alignment rod 502 to the leg mechanical axis and makes a subjective determination that the leg is correctly positioned. The surgeon can increase accuracy by pre-identifying points on the mechanical axis. The surgeon has the option of making adjustments if drop alignment rod 502 indicates a potential positional error. Drop alignment rod 502 can be tapered having a section with a greater width than opening 114 to retain it in place and prevent it from falling through. Other embodiments to retain drop alignment rod 502 can also be used.

Alternatively, drop alignment rod 502 can be a smart alignment aid for the surgeon that incorporates electronics similar to that described in FIG. 2. In general, drop alignment rod includes sensors to allow depiction of the mechanical axis. For example, drop alignment rod 502 can incorporate sensors to identify position in three-dimensional space. The electronics would allow drop alignment rod 502 to communicate with pre-operative defined locations or locations that are identified at the time of surgery using locator electronics. The drop rod can house light emitters to depict an axis as will be discussed in more detail hereinbelow. The electronics can include communication to external processing unit 406 with a graphic user interface that has the mechanical axis loaded therein.

FIG. 6 is a lateral view of a dynamic distractor 100 in a knee joint coupled to a cutting block 602 in accordance with an exemplary embodiment. In general, the surgeon utilizes surgical tools to obtain appropriate bony cuts to the skeletal system. The surgical tools are often mechanical devices used to achieve gross alignment of the skeletal system prior to or during an implant surgery. In the knee example, mechanical alignment aids are often used during orthopedic surgery to check alignment of the bony cuts of the femur and tibia to the mechanical axis of the leg. The mechanical alignment aids are not integrated together, take time to deploy, and have limited accuracy. Dynamic distractor 100 in concert with cutting block 602 is an integrated system for achieving alignment that can greatly reduce set up time thereby minimizing stress on the patient.

As illustrated, the leg is in flexion having a relational position of 90 degrees between femur 402 and tibia 404. A femoral rod 608 is coupled through the intermedullary canal of femur 402. A cutting block 602 is attached to the femoral rod 608 for shaping a portion of the surface of the distal end of femur 402 for receiving a femoral implant. Knee replacement surgery entails cutting bone a certain thickness and implanting a prosthesis to allow pain relief and motion. During the surgery, instruments are used to assist the surgeon in performing the surgical steps appropriately. Dynamic distractor 100 aids the surgeon by allowing quantitative measurement of the gap and parameter measurement during all stages of the procedure. For the knee, the data can supplement a surgeon's “feel” by providing data on absolute loading in each compartment, the load differential between compartments, positional information, and alignment information.

The portion of the surface of the distal end of femur 402 in contact with dynamic distractor 100 is shaped in a subsequent step. In a non-limiting example, the portion of the condyles in contact with superior surface 102, sensor 108, and sensor 110 are the natural condyles of the femur. The portion of the distal end of femur 402 being shaped corresponds to the condyle portion that would be in contact with the final spacer while the leg is in extension and partially through the range of motion. In at least one exemplary embodiment, an uprod 604 of dynamic distractor 100 couples to cutting block 602. Uprod 604 aids in the alignment of the cutting block 602 to dynamic distractor 100 and tibia 404. Uprod 604 further stabilizes cutting block 602 to prevent movement as the distal end of femur 402 is shaped.

In one embodiment, handle 112 is removed and an uprod 604 is attached to threaded rod 212. The uprod 604 can include a hinge that positions rod 604 vertically to mate with cutting block 602. Alternatively, handle 112 can include a hinge. In this example, handle 112 is uprod 604 and is inserted into cutting block 602. Furthermore, uprod 604 can be fastened or coupled to an opening or feature in handle 112 to couple to cutting block 602. In general, uprod 604 is placed at a right angle to the inferior surface of lower support structure 204 of dynamic distractor 100. In a prior step, the leg alignment can be checked to ensure it is within a predetermined range of the mechanical axis. In one embodiment, uprod 604 aligns approximately to the mechanical axis to secure cutting block 602 in an appropriate geometric orientation. Cutting block 602 includes a channel 606 for receiving uprod 604. Uprod 604 can be adjustable in length that simplifies insertion. As previously mentioned, uprod 604 is attached to dynamic distractor 100 to align with the mechanical axis of the leg corresponding to tibia 404. Fitted in the opening and into channel 606, uprod 604 maintains a positional relationship between cutting block 602, dynamic spacer block 100, femur 402, and tibia 404. More specifically, the proximal surface of tibia 404 is aligned to the mechanical axis thereby fixing the position of femur 402 and cutting block 602 in a similar fixed geometric relational position. Thus, the distal end of femur 402 is cut having surfaces parallel to the proximal tibial surface by coupling dynamic distractor 100 to cutting block 602 through uprod 604.

FIG. 7 is an anterior view of a cutting block 602 coupled to dynamic distractor 100 in accordance with an exemplary embodiment. Cutting block 602 is attached to the distal end of femur 402. Femoral rod 608 extends through cutting block 602 into the intermedullary canal. Uprod 604 is shown extending vertically into channel 606 of cutting block 602. In combination, femoral rod 608 and uprod 604 prevent movement and maintain alignment of the cutting block to the leg mechanical axis. As shown, cutting block 602 is illustrated as rectangular in shape. Cutting block 602 is shaped to form a predetermined bone shape on the distal end of femur 402 for receiving a femoral implant. Thus, the shape of cutting block 602 can vary significantly from that shown depending on the implant. The size of the cutting block 602 corresponds to the distal end size and the femoral implant selected by the surgeon. The surgeon uses a bone saw to remove portions of the distal end of femur 402 in conjunction with cutting block 602. In general, the cutting block 602 acts as a template to guide the bone saw and to cut the distal end of the femur in a predetermined geometric shape. As disclosed previously in the example, the portion of the distal end of femur 404 that is shaped corresponds to the contact portion of the condyles when the leg is in full extension and partially in flexion (e.g. <90 degrees). As mentioned previously, the portion of the distal end of femur 402 in contact the superior surface 102 of dynamic distractor 100 is shaped in a subsequent step.

FIG. 8 is an illustration of dynamic distractor 100 including alignment in accordance with an exemplary embodiment. Dynamic distractor 100 includes one or more recesses 802 in a handle 804 for receiving an alignment aid to align a leg along the mechanical axis. In one embodiment, handle 804 can be handle 112 that includes recesses 802. Alternatively, handle 804 is a separate handle for dynamic distractor 100. Prior to checking alignment, handle 112 is removed from dynamic distractor 100. Handle 804 is coupled to threaded rod 212.

Initial bony cuts are made in alignment with the mechanical axis of the leg. In the knee example, the alignment aid is used to check that the femur and the tibia are correctly oriented prior to cutting. The surfaces of the bones are cut in alignment to the mechanical axis using a jig. Thus, the cut surfaces on the distal end of the femur and the proximal end of the tibia are aligned and can be used as a reference surfaces during the procedure. Alternatively, the alignment aid can be used to verify alignment throughout the procedure. Recesses 802 can be thru-holes in handle 804. In a non-limiting example, the alignment aid is one or more lasers 808. Lasers 808 are used to point along the mechanical axis of the leg. In one embodiment, lasers 808 are used to check alignment of the leg. A first laser is used to point in the direction of the hip joint. A second laser is used to point towards the ankle. In one embodiment, the first and second lasers are integrated into a single body. Handle 804 further comprises a hinge 806 to change the angle at which lasers 808 are directed. The housing of lasers 808 includes a power source such as a battery to generate the monochromatic light beam. The housing fits within one of recesses 802 or a thru-hole. Lasers 808 can be a disposable item that is discarded after the surgery is completed.

FIG. 9 is a side view of a leg in extension with dynamic distractor 100 in the knee joint region in accordance with an exemplary embodiment. The mechanical axis of the leg is approximately a straight line from the center of the femoral head through the knee joint and extending to the middle of the ankle joint. In a correctly aligned knee joint, the mechanical axis will pass approximately through the center of the knee joint. Alignment can be checked when dynamic distractor 100 is positioned in the knee joint region. As illustrated, the leg is in extension with handle 804 extending vertically from the knee joint region. In one embodiment, a target 902 is placed in an ankle or toe region of the foot in a path corresponding to center of the ankle on the mechanical axis of the leg. Similarly, a target 904 is placed in a path corresponding to the center of the head of the femur on the mechanical axis of the leg. Targets 902 are placed at a height similar to that of lasers 808. Lasers 808 are installed in the handle with one pointing in the direction of the hip joint and another pointing in the direction of the ankle joint. From the top view, lasers 808 send out a beam of light from a position that corresponds to the center of the knee. In one embodiment, the direction of the beam from lasers 808 is directed perpendicular to a plane of the prepared surface of the proximal end of the tibia.

Lasers 808 are directed perpendicular to the inferior surface of dynamic distractor 100. The placement of dynamic distractor 100 on the prepared tibial surface is such that handle 804 extends vertically at a point corresponding to the center of the knee joint. The leg is aligned correctly when the beams from lasers 808 hit the target at the points corresponding to the center of the head of the femur and the center of the ankle. Lasers 808 are positioned to align with the center of the knee joint. The surgeon can make adjustments to the bone surfaces or utilize soft tissue release to achieve alignment with the leg mechanical axis when lasers 808 are misaligned to the target. The system can be used to give a subjective or a measured determination on leg alignment in relation to a vargus or valgus alignment. The direction of misalignment in viewing targets 902 and 904 will dictate the type of correction and how much correction needs to be made. In an alternate embodiment, lasers 808 can be aimed such that the beam is viewable along the leg in a region by the center of the femoral head and the center of the angle. The surgeon can use this as a subjective visual gauge to determine if the leg is in alignment to the mechanical axis and respond appropriately, depending on what is viewed.

FIG. 10 is a top view of a leg in extension with dynamic distractor 100 in the knee joint area in accordance with an exemplary embodiment. Dynamic distractor 100 can measure spacing between the distal end of the femur and the tibia, loading in each compartment, and differential loading between compartments. The data can be sent to a processing unit and display as disclosed hereinabove. As mentioned previously, the mechanical axis of the leg corresponds to a straight line from the center of the ankle, through the center of the knee, and the center of the femoral head. Targets 902 and 904 are respectively located overlying the mechanical axis in an area local to the ankle and the hip regions. Targets 902 and 904 can include a fixture such as a strap, brace, or jig to hold the targets temporarily along the mechanical axis. Lasers 808 are enabled and placed in handle 804. The figure illustrates that targets 902 and 904 are on approximately the same plane as beams emitted by lasers 808 such that the beams impinge on a target unless grossly misaligned. Targets 902 and 904 can include calibration markings to indicate a measure of the misalignment. Alternatively, handle 804 is hinged allowing adjustment of the angle at which the beam from lasers 808 is directed. The direction of the lasers 808 corresponds to the plane of the bone cuts for the implant and the balance of the joint. Thus, the surgeon using a single device has both quantitative and subjective data relating to alignment to the mechanical axis, loading, balance, leg position, and gap measurement that allows gross/fine tuning during surgery that results in more consistent orthopedic outcomes.

FIG. 11 is an illustration of a system 1100 for measuring one or more parameters of a biological life form in accordance with an exemplary embodiment. In a non-limiting example, the system provides real time measurement capability to a surgeon of one or more parameters needed to assess a muscular-skeletal system. System 1100 comprises a plurality of spacer blocks 1102, a distractor 1104, sensors 1106, targets 1110, lasers 1114, a charger 1116, a receiver 1118, a reader 1120, a processing unit 1122, a display 1124 a drop rod 1126, an uprod 1128, a cutting block 1130, a handle 1132, a dynamic data repository and registry 1134. The system is adaptable to provide accurate measurements of parameters such as distance, weight, strain, pressure, wear, vibration, viscosity, and density to name but a few. In one embodiment, system 1100 is used in orthopedic surgery and more specifically to provide intra-operative measurement during joint implant surgery. System 1100 is adapted for orthopedic surgery and more specifically for knee surgery to illustrate operation of the system.

In general, system 1100 provides alignment and parameter measurement system for providing quantitative measurement of the muscular-skeletal system. In one embodiment, system 1100 is integrated with tools commonly used in orthopedics to reduce an adoption cycle to utilize new technology. System 1100 replaces standalone equipment or dedicated equipment that is used only for a small number of procedures that justifies the extra time and set up required to use this type of equipment. Furthermore, it is well known, that dedicated equipment can cost hundreds of thousands or millions of dollars for a single device. Many hospitals and other healthcare facilities cannot afford the high capital cost of these types of systems. Moreover, specialized equipment such as robotic systems or alignment systems for orthopedic surgery typically has a large footprint. The large footprint creates space and cost issues. The equipment must be stored, set up, calibrated, placed in the operating room, and then removed.

Conversely, measurement and alignment components of system 1100 are low cost disposables that make the measurement technology more accessible to the general public. There is no significant capital investment required to use the system. Moreover, payback begins immediately with use in providing quantitative information related to procedures thereby allowing analysis of outcomes based how the parameters being measured affect the procedure being measured. The data is used to initiate predetermined specifications for the procedure that can be measured and adjusted during the course of the procedure thereby optimizing the outcomes and reducing revisions. As mentioned previously, system 1100 can be used or integrated with tools that the majority of orthopedic surgeons have substantial experience or familiarity using on a regular basis. In one embodiment, sensors 1106 are placed in a spacer that separates two surfaces of the muscular-skeletal system. In a non-limiting example, the spacer can be spacer blocks 1102 or distractor 1104. A measurement of the parameter is taken after the spacer is inserted between at least two surfaces of the muscular-skeletal system. Sensors 1106 are in communication with processing unit 1122. In one embodiment, the processing unit 1122 is outside the sterile field and includes display 1124 and a GUI to provide the data in real time to the surgeon. Thus, the learning cycle can be very short to provide real time quantitative feedback to the surgeon as well as storing the data for subsequent use.

In a non-limiting example a spacer separates two surfaces of the muscular-skeletal system. The spacer has an inferior surface and a superior surface that contact the two surfaces. The spacer can have a fixed height or can have a variable height. The fixed height spacer is known as spacer blocks 1102. Each spacer block 1102 has a different thickness. The variable height spacer is known as the distractor 1104. The surface area of spacer blocks 1102 and distractor 1104 that couple to the surfaces of the muscular-skeletal system can also be provided in different sizes. The handle 1132 extends from the spacer and typically resides outside or beyond the two surface regions. The handle 1132 is used to direct the spacer between the two surfaces. In one embodiment, the handle 1132 operatively couples to a lift mechanism of the distractor 1104 to increase and decrease a gap between the superior and inferior surfaces of the spacer. The spacer and handle 1132 is part of system 1100 to measure alignment of the muscular-skeletal system. In one embodiment, at least one of the surfaces of the muscular-skeletal system that contacts the spacer has an optimal alignment to a mechanical axis of the muscular-skeletal system. The system measures the surface to mechanical axis alignment. In a non-limiting example, the misalignment can be corrected by a surgeon when the surface is misaligned to the mechanical axis outside a predetermined range as disclosed below.

Knee replacement surgery entails cutting bone having a predetermined spacing and implanting a prosthesis to allow pain relief and motion. During the surgery, instruments are used to assist the surgeon in performing the surgical steps appropriately. The majority of surgeons continue to use passive spacers to aid in defining the gaps between the cut bones. The thickness of the final insert is selected after placing one or more trial inserts in the artificial joint implant. The determination of whether the implanted components are correctly installed is still to a large extent by “feel” of the surgeon through movement of the leg. In general, spacer blocks 1102 and distractor 1104 of system 1100 is a spacer having an inferior and superior surface that separate at least two surfaces of the muscular-skeletal system. In the knee example, the inferior and superior surfaces are inserted between the femur and tibia of the knee. At least one of the inferior or superior surfaces of spacer blocks 1102 and distractor 1104 have a cavity or recess for receiving sensors 1106. In one embodiment, the cavity is on the superior surface of spacer blocks 1102 and distractor 1104. A gap between the surfaces of distractor 1104 is adjustable as described hereinabove. Tray 1108 includes multiple spacer blocks 1102 each having a different thickness. Thus, spacer blocks 1102 and distractor 1104 provide the surgeon with more than one option to measure spacing, alignment, and loading during the procedure. A benefit of the system is the familiarity that the surgeon will have with using similar type devices thereby reducing the learning curve to utilize system 1100. Furthermore, system 1100 can comprise spacer blocks 1102 and distractor 1104 having spacer blocks having different sized superior and inferior surface areas to more readily accommodate different bone shapes and sizes.

In general, a rectangle is formed by the bony cuts during surgery. The imaginary rectangle is formed between the cut distal end of a femur and the cut proximal end of tibia in extension and in conjunction with the mechanical axis of the lower leg. The prepared surfaces of the femur and tibia are shaped to respectively receive a femoral implant and a tibial implant. The femoral and tibial surfaces are parallel to one another when the leg is in extension and in flexion at 90 degrees. A predetermined width of the rectangle is the spacing between the planar surface cuts on femur and tibia. The predetermined width corresponds to the thickness of the combined orthopedic implant device comprising the femoral implant, an insert, and the tibial implant. A target thickness for the initial cuts is typically on the order of twenty millimeters. The insert is inserted between the installed femoral implant and the tibial implant. In a full knee implant the insert has two bearing surfaces that are shaped to receive the condyle surfaces of the femoral implant.

In at least one exemplary embodiment, sensors 1106 can measure load and position. Sensors 1106 are placed in a charger 1116 prior to the implant surgery being performed. Charger 1116 provides a charge to an internal power source within sensors 1106 that will sustain sensor measurement and data transmission throughout the surgery. Charger 1116 can fully charge sensor 1106 or be used as a precautionary measure to insure the temporary power storage is holding sufficient charge. Charger 1116 can be charge via a wireless connection through a sterilized packaging. Sensors 1106 are in communication with processing unit 1122. Sensors 1106 include a transmitter for sending data. Processing unit 1122 can be logic circuitry, a digital signal processor, microcontroller, microprocessor, or part of a system having computing capability. As shown, processing unit 1122 is a notebook computer having a display 1124. The communication between sensors 1106 and processing unit 1122 can be wired or wireless. In one embodiment, receiver 1118 is coupled to processing for wireless communication. A carrier signal for data transmitted from sensors 1106 can be radio frequency, infrared, optical, acoustic, and microwave to name but a few. In a non-limiting example, receiver 1118 receives data via a radio frequency signal in a short range unlicensed band sufficient for transmission within the size of an operating room. Information from processing unit 1122 can be sent through the internet to dynamic data repository and registry 1134 for long-term storage. The dynamic data repository and registry 1134 will be discussed in greater detail hereinbelow. In one embodiment, the data is stored in a server 1136 or as part of a larger database.

The surgeon uses system 1100 to aid in the preparation of bone surfaces, to measure loading, to measure balance, check alignment, and tune the knee joint prior to a final insert being installed. A reader 1120 is used to scan in information prior to or during the surgery. In one embodiment, the reader 1120 can be wired or wirelessly coupled to the processing unit 1122.

Processing unit 1122 can process the information, display it on display 1124 for use during a procedure, and store it in memory or a database for long-term use. For example, information on components used in the surgery such as the artificial knee components or components of system 1100 can be converted to an electronic digital form using reader 1120 during the procedure. Similarly, patient information or procedural information can also be scanned in, input manually, or captured by other means to processing unit 1122.

The leg is placed in extension and the knee joint is exposed by incision. In one embodiment, the surgeon prepares the proximal end of the tibia. The prepared tibial surface is typically at a 90-degree angle to the mechanical axis of the leg. Targets 1110 are placed overlying the mechanical axis near the ankle and hip joint. The surgeon can select one of the spacer blocks 1102 or dynamic distractor 1104 for insertion in the joint region. The selected spacer block has a predetermined thickness that is imprinted on the spacer block or can be displayed on display 1124 by scanning the information. Alternatively, distractor 1104 is distracted by the surgeon within the joint region. The amount of distraction can be read off of distractor 1104 or can be displayed on display 1124.

In a non-limiting example of aligning two surfaces of the muscular-skeletal system, alignment of the leg to the mechanical axis is measured or a subjective check can be performed by the surgeon using an alignment aid. At least one component of the alignment aid is disposable. The alignment aid comprises lasers 1114 in the handle 1112 of the selected spacer block or a handle 1132 of distractor 1104 with the leg in extension. The alignment aid further includes targets 1110. Targets 1110, lasers 1114, or both can be disposable. Accelerometers in sensors 1106 provide positional information of the tibia in relation to the femur. For example, display 1124 will indicate that the angle between the tibia and femur is 180 degrees when the leg is in extension. The beam from lasers 1114 hit targets 1110 and provides a measurement of the position of the tibia in relation to the femur compared to the mechanical axis of the leg. In one embodiment, lasers 1114 are centrally located above the knee joint overlying the mechanical axis of the leg. The beam from lasers 1114 is directed perpendicular to the plane of the surface of the tibia. The beam from lasers 1114 will align and overlie the mechanical axis if the surface of the tibia is the perpendicular to the mechanical axis. The beam from lasers 1114 would hit targets 1110 at a point that indicates alignment with the mechanical axis. A valgus or vargus reading can be read where the beam hits the calibrated markings of targets 1110 if the leg is not aligned. The surgeon can then make an adjustment to bring the leg into closer alignment to the mechanical axis if deemed necessary. Jigs or cutting blocks can also be used in conjunction with lasers 1114 and targets 1110 to check alignment prior to shaping. The jigs or cutting blocks are used to shape the bone for receiving an implant. The distal end of femur and the proximal end of tibia are shaped for receiving orthopedic joint implants. In a further embodiment, sensors can be attached to the cutting jigs or devices to aid the surgeon in optimizing the depth and angles of their cuts.

Sensors 1106 measure the loading in each compartment for the depth or thickness of the selected spacer block or the distracted gap generated by distractor 1104. In one embodiment, the loading measurements are taken after the initial bone cuts are determined to be within a predetermined range of alignment with the mechanical axis. The load measurement in each compartment is either high, within an acceptable predetermined range, or low. A load measurement above a predetermined range can be adjusted by removing bone material, selecting a thinner spacer block, adjusting the gap of distractor 1104, or by soft tissue release. In general, the gap between the femur and tibia at which the measurement taken corresponds to a final insert thickness. In one embodiment, the gap is selected to result in a load measurement on the high side of the predetermined range to allow for fine-tuning through soft tissue release. Conversely, a load measurement below the predetermined range can be increased using the next thicker spacer block or by increasing the gap of distractor 1104. Data from sensors 1106 is transmitted to processing unit 1122. Processing unit 1122 processes the data and displays the information on display 1124 for use by the surgeon to aid in fine-tuning. Display 1124 would further provide positional information of the femur and tibia. The absolute loading in each compartment is measured and displayed on display 1124. As is known by one skilled in the art, the gap created by the bone cuts accommodates the combined thickness of the femoral implant, the tibial implant, and the insert. The gap using spacer blocks 1102 or distractor 1104 takes into account the combined thickness of the implant components. In a non-limiting example, the gap is chosen based on the availability of different thicknesses of the final insert. Thus, the loading on the final or permanent insert placed in the joint will measure within the predetermined range as prepared by using system 1100.

Balance is a comparison of the load measurement of each condyle surface. In general, balance correction is performed when the measurements exceed a predetermined difference value. Soft tissue balancing is achieved by loosening ligaments on the side of the compartment that measures a higher loading. In one embodiment, system 1100 allows the surgeon to read the loading measurement for each compartment on one or more displays on spacer blocks 1102 or distractor 1104. Another factor is that the difference in loading can be due to surface preparation of the bony cuts for either femoral implant or the tibial implant. If the differential is substantial, the surgeon has the option of removing bone on either surface underlying the implant to reduce the loading difference.

In one embodiment, the absolute load adjustments and balance adjustments are performed by soft tissue release in response to the assessment of each compartment. Load and balance adjustment is achieved with the selected spacer block or distractor 1104 in the knee joint. Spacer blocks 1102 and distractor 1104 have a gap to provide peripheral access between the superior and inferior surfaces of the device thereby giving the surgeon access to perform soft tissue release to either compartment with real time load measurement shown on display 1124. In at least one exemplary embodiment, handles 1112 of spacer blocks 1102 or handle 1132 of distractor 1104 can be removed or positioned. Handles 1112 or handle 1132 can be positioned away from the surgical area or removed allowing the surgeon access to perform soft tissue release. The soft tissue release is performed to each compartment to adjust the absolute loading within the predetermined range and further adjustment can be performed to reduce the differential loading between the compartments to within a predetermined differential range. Consequently, the surgical outcome is a function of system 1100 as complemented with the surgeon's abilities but not so highly dependent alone on the surgeon's skill. The device captures the “feel” of how an implanted device should properly operate to improve precision and minimize variation including haptic and visual cues.

A similar process is applied with the lower leg in flexion with tibia forming a 90-degree angle with the femur. In one embodiment, one or more bone cuts are made to the distal end of femur for receiving the femoral implant. The preparation of the femur corresponds to the leg in extension. As disclosed above, the selected spacer block or distractor 1104 can be coupled using an uprod from handle 1112 or handle 1132 to cutting block 1130 to aid in alignment and stability. In particular, the surface of the distal end of femur is cut parallel to the prepared surface of the tibia with the leg in flexion. The bone cut to the femur yields an imaginary rectangle formed with the parallel surfaces of femur and tibia when the leg is in extension. It should be noted that a portion of the femoral condyle is in contact with the selected spacer block or distractor 1104 with the leg in flexion and this region is not prepared at this time. In a subsequent step, the remaining surface of the distal end of the femur is prepared. The width of the gap in extension and in flexion between the cut distal end of the femur and the prepared tibia surface corresponds to the thickness of the combined orthopedic implant device comprising the femoral implant, final insert, the tibial implant. Ideally, the measured the gap under equal loading in flexion (e.g. the tibia forms a 90 degree angle with the femur) and extension is similar or equal. The prepared femoral surfaces and the prepared tibial surfaces are parallel throughout the range of motion and perpendicular to the mechanical axis of the leg.

Load measurements are made with the leg in flexion and the selected spacer block or distractor 1104 between the distal end of the femur and the tibial surface. In a non-limiting example, the measurements as described above should be similar to the measurements made in extension. Adjustments to the load value and the balance between compartments can be made by soft tissue release, or femoral component rotation in flexion with the selected spacer block or distractor 1104 in place. Alternatively, the femoral implant can be seated on the distal end of the femur and measurements taken. Adjustments can be made with the femoral implant in place. Furthermore, a gap generated by distractor 1104 can be adjusted to accommodate differences due to the femoral implant if required.

The leg with the selected spacer block or distractor 1104 can be taken through a complete range of motion. The loading in each compartment can be monitored on display 1124 and processed by processing unit 1122 over the range of motion. Processing unit can compare different points in the range of motion to the predetermined load range and the predetermined differential load range. Should an out of range/value condition occur, the surgeon can view and note the position of the femur and tibia position on display 1124 and take steps to bring the implant within specification. The surgeon can complete the implant surgery having knowledge that both qualitative and quantitative information was used during the procedure to ensure correct installation. In one embodiment, sensors 1106, disposable targets 1110, and lasers 1114 are disposed of upon completion of the surgery.

For example, the sensors will enable the surgeon to measure joint loading while utilizing soft tissue tensioning to adjust balance and maximize stability of an implanted joint. Similarly, measured data in conjunction with positioning can be collected before and during surgery to aid the surgeon in ensuring that, the implanted device has an equivalent geometry and range of motion.

Element 1340 of FIG. 12 depicts an exemplary diagrammatic representation of a machine in the form of a computer system within which a set of instructions, when executed, may cause the machine to perform any one or more of the methodologies discussed above. In some embodiments, the machine operates as a standalone device. In some embodiments, the machine may be connected (e.g., using a network) to other machines. In a networked deployment, the machine may operate in the capacity of a server or a client user machine in server-client user network environment, or as a peer machine in a peer-to-peer (or distributed) network environment.

The machine may comprise a server computer, a client user computer, a personal computer (PC), a tablet PC, a laptop computer, a desktop computer, a control system, a network router, switch or bridge, or any machine capable of executing a set of instructions (sequential or otherwise) that specify actions to be taken by that machine. It will be understood that a device of the present disclosure includes broadly any electronic device that provides voice, video or data communication. Further, while a single machine is illustrated, the term “machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein.

The computer system may include a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU, or both), a main memory and a static memory, which communicate with each other via a bus. The computer system may further include a video display unit (e.g., a liquid crystal display (LCD), a flat panel, a solid-state display, or a cathode ray tube (CRT)). The computer system may include an input device (e.g., a keyboard), a cursor control device (e.g., a mouse), a disk drive unit, a signal generation device (e.g., a speaker or remote control) and a network interface device.

The disk drive unit may include a machine-readable medium on which is stored one or more sets of instructions (e.g., software) embodying any one or more of the methodologies or functions described herein, including those methods illustrated above. The instructions may also reside, completely or at least partially, within the main memory, the static memory, and/or within the processor during execution thereof by the computer system. The main memory and the processor also may constitute machine-readable media.

Dedicated hardware implementations including, but not limited to, application specific integrated circuits, programmable logic arrays and other hardware devices can likewise be constructed to implement the methods described herein. Applications that may include the apparatus and systems of various embodiments broadly include a variety of electronic and computer systems. Some embodiments implement functions in two or more specific interconnected hardware modules or devices with related control and data signals communicated between and through the modules, or as portions of an application-specific integrated circuit. Thus, the example system is applicable to software, firmware, and hardware implementations.

In accordance with various embodiments of the present disclosure, the methods described herein are intended for operation as software programs running on a computer processor. Furthermore, software implementations can include, but not limited to, distributed processing or component/object distributed processing, parallel processing, or virtual machine processing can also be constructed to implement the methods described herein.

The present disclosure contemplates a machine readable medium containing instructions, or that which receives and executes instructions from a propagated signal so that a device connected to a network environment can send or receive voice, video or data, and to communicate over the network using the instructions. The instructions may further be transmitted or received over a network via the network interface device.

While the machine-readable medium is shown in an example embodiment to be a single medium, the term “machine-readable medium” should be taken to include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) that store the one or more sets of instructions. The term “machine-readable medium” shall also be taken to include any medium that is capable of storing, encoding or carrying a set of instructions for execution by the machine and that cause the machine to perform any one or more of the methodologies of the present disclosure.

The term “machine-readable medium” shall accordingly be taken to include, but not be limited to: solid-state memories such as a memory card or other package that houses one or more read-only (non-volatile) memories, random access memories, or other re-writable (volatile) memories; magneto-optical or optical medium such as a disk or tape; and carrier wave signals such as a signal embodying computer instructions in a transmission medium; and/or a digital file attachment to e-mail or other self-contained information archive or set of archives is considered a distribution medium equivalent to a tangible storage medium. Accordingly, the disclosure is considered to include any one or more of a machine-readable medium or a distribution medium, as listed herein and including art-recognized equivalents and successor media, in which the software implementations herein are stored.

Although the present specification describes components and functions implemented in the embodiments with reference to particular standards and protocols, the disclosure is not limited to such standards and protocols. Each of the standards for Internet and other packet switched network transmission (e.g., TCP/IP, UDP/IP, HTML, HTTP) represent examples of the state of the art. Such standards are periodically superseded by faster or more efficient equivalents having essentially the same functions. Accordingly, replacement standards and protocols having the same functions are considered equivalents.

The illustrations of embodiments described herein are intended to provide a general understanding of the structure of various embodiments, and they are not intended to serve as a complete description of all the elements and features of apparatus and systems that might make use of the structures described herein. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. Other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Figures are also merely representational and may not be drawn to scale. Certain proportions thereof may be exaggerated, while others may be minimized. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense.

FIG. 12 and FIG. 13 illustrate a communication network 1300 for measurement and reporting in accordance with an exemplary embodiment. Briefly, the communication network 1300 expands broad data connectivity to other devices or services. As illustrated, the measurement and reporting system 1300 can be communicatively coupled to the communications network 1300 and any associated systems or services.

As one example, the measurement system 1355 can share its parameters of interest (e.g., angles, load, balance, distance, alignment, displacement, movement, rotation, and acceleration) with remote services or providers, for instance, to analyze or report on surgical status or outcome. This data can be shared for example with a service provider to monitor progress or with plan administrators for surgical monitoring purposes or efficacy studies. The communication network 1300 can further be tied to an Electronic Medical Records (EMR) system to implement health information technology practices. In other embodiments, the communication network 1300 can be communicatively coupled to HIS Hospital Information System, HIT Hospital Information Technology and HIM Hospital Information Management, EHR Electronic Health Record, CPOE Computerized Physician Order Entry, and CDSS Computerized Decision Support Systems. This provides the ability of different information technology systems and software applications to communicate, to exchange data accurately, effectively, and consistently, and to use the exchanged data.

The communications network 1300 can provide wired or wireless connectivity over a Local Area Network (LAN) 1301, a Wireless Local Area Network (WLAN) 1305, a Cellular Network 1314, and/or other radio frequency (RF) system (see FIG. 4). The LAN 1301 and WLAN 1305 can be communicatively coupled to the Internet 1320, for example, through a central office. The central office can house common network switching equipment for distributing telecommunication services. Telecommunication services can include traditional POTS (Plain Old Telephone Service) and broadband services such as cable, HDTV, DSL, VoIP (Voice over Internet Protocol), IPTV (Internet Protocol Television), Internet services, and so on.

The communication network 1300 can utilize common computing and communications technologies to support circuit-switched and/or packet-switched communications. Each of the standards for Internet 1320 and other packet switched network transmission (e.g., TCP/IP, UDP/IP, HTML, HTTP, RTP, MMS, SMS) represent examples of the state of the art. Such standards are periodically superseded by faster or more efficient equivalents having essentially the same functions. Accordingly, replacement standards and protocols having the same functions are considered equivalent.

The cellular network 1314 can support voice and data services over a number of access technologies such as GSM-GPRS, EDGE, CDMA, UMTS, WiMAX, 2G, 3G, WAP, software defined radio (SDR), and other known technologies. The cellular network 1314 can be coupled to base receiver 1310 under a frequency-reuse plan for communicating with mobile devices 1302.

The base receiver 1310, in turn, can connect the mobile device 1302 to the Internet 1320 over a packet switched link. The internet 1320 can support application services and service layers for distributing data from the measurement system 1355 to the mobile device 1302. The mobile device 1302 can also connect to other communication devices through the Internet 1320 using a wireless communication channel.

The mobile device 1302 can also connect to the Internet 1320 over the WLAN 1305. Wireless Local Access Networks (WLANs) provide wireless access within a local geographical area. WLANs are typically composed of a cluster of Access Points (APs) 1304 also known as base stations. The measurement system 1355 can communicate with other WLAN stations such as laptop 1303 within the base station area. In typical WLAN implementations, the physical layer uses a variety of technologies such as 802.11b or 802.11g WLAN technologies. The physical layer may use infrared, frequency hopping spread spectrum in the 2.4 GHz Band, direct sequence spread spectrum in the 2.4 GHz Band, or other access technologies, for example, in the 5.8 GHz ISM band or higher ISM bands (e.g., 24 GHz, etc).

By way of the communication network 1300, the measurement system 1355 can establish connections with a remote server 1330 on the network and with other mobile devices for exchanging data. The remote server 1330 can have access to a database 1340 that is stored locally or remotely and which can contain application specific data. The remote server 1330 can also host application services directly, or over the internet 1320.

It should be noted that very little data exists on implanted orthopedic devices. Most of the data is empirically obtained by analyzing orthopedic devices that have been used in a human subject or simulated use. Wear patterns, material issues, and failure mechanisms are studied. Although, information can be garnered through this type of study it does yield substantive data about the initial installation, post-operative use, and long term use from a measurement perspective. Just as each person is different, each device installation is different having variations in initial loading, balance, and alignment. Having measured data and using the data to install an orthopedic device will greatly increase the consistency of the implant procedure thereby reducing rework and maximizing the life of the device. In at least one exemplary embodiment, the measured data can be collected to a database where it can be stored and analyzed. For example, once a relevant sample of the measured data is collected, it can be used to define optimal initial measured settings, geometries, and alignments for maximizing the life and usability of an implanted orthopedic device.

FIG. 14 is an exemplary method 1400 for distracting surfaces of the muscular-skeletal system in accordance with an exemplary embodiment. The method can be practiced with more or less than the number of steps shown and is not limited to the order shown. In a step 1402, sterilized sensors are removed from packaging. The sensors are powered up and enabled for sensing. One or more sensors are placed in a dynamic distractor. For example, the dynamic distractor used for a knee application will have two cavities for measuring each compartment of the knee. More specifically, a superior surface of the dynamic distractor has two cavities for receiving the sensors. The dynamic distractor is also in a sterilized condition.

In a step 1404, the dynamic distractor is inserted in the muscular-skeletal system. The superior and an inferior surface of the dynamic distractor is in contact with a first and second surface of the muscular-skeletal system. Continuing with the knee example, the inferior surface of the dynamic distractor is placed in the knee joint facing the proximal end of the tibia and the superior surface is placed in the knee joint facing the distal end of the femur. In one embodiment, the distal end of the tibia is prepared having a flat surface that is perpendicular to the mechanical axis of the leg.

In a step 1406, a handle of the dynamic distractor is rotated to increase a gap between the inferior and superior surfaces. As the gap increases the inferior surface is in contact with the distal end of the tibia. Similarly, the superior surface of the dynamic distractor contacts the distal end of the femur. In one embodiment, the condyles of the distal end of the femur contact the sensors of each compartment. In a non-limiting example, the dynamic distractor is placed in the knee joint such that the dynamic distractor is centrally located in the knee joint. The mechanical axis of the leg will align to the center of the dynamic distractor between the medial and lateral sides of the device. The handle of the dynamic distractor extends away from the knee joint on the mechanical axis of the leg.

In a step 1408, a parameter is measured by the sensors. In the example, the sensors measure load. More specifically the load in each compartment of the knee is measured at the height or gap created by the dynamic distractor. In one embodiment, the gap or height of distraction relates to the thickness of one or more components of an artificial joint such as the knee joint. The gap can correspond to the thickness of a final insert of the artificial joint. In general, final inserts typically comprise a polymer that provide a low-friction low-wear bearing surface. The final inserts are typically provided in a number of predetermined thicknesses of which one is selected for permanent insertion.

In a step 1410, the one or more sensors are removed from dynamic distractor. In general, the sensor is removed after the dynamic distractor is no longer needed in the surgery. In a step 1412, the sensor is disposed of after the surgery is completed. For example, the sensors can be disposed of as biological waste. The sensors as a disposable item alleviate substantial problems facing the health care industry. The high capital cost of traditional of surgical equipment often prevent purchase thereby preventing potentially beneficial equipment from being used. Disposables also eliminate the costly and time-consuming process of sterilization. The low cost of the sensors eliminates the capital cost issue thereby opening quantitative measurement of joint implants to a much larger audience. The result will be more consistent surgeries, ability to fine tune the surgery, longer implant life, and reduced post surgical complications to name but a few.

Steps 1414, 1416, and 1418 relate to optimal loading on the final insert for maximum joint life. In general, it is not desirable for the implanted joint to be too tight or loose. In a step 1414, the gap is increased until the loading is within a predetermined loading range and the gap corresponds to an available final insert thickness. In one embodiment, the gap is selected for a final insert thickness that measures a loading above the median of the predetermined range to allow for soft tissue release back within the predetermined range. In a step 1416, the gap is measured when the sensors measure loading within the predetermined range. Alternatively, the dynamic distractor can increase or decrease gaps incrementally that correspond to available inserts. In a step 1418, the insert is selected. As mentioned previously, the measured gap when the loading is within the predetermined range may not correspond to a final insert thickness. The surgeon can increase or decrease the gap to an available insert thickness (and measure load in each compartment) then select an insert based on subsequent steps of the procedure to be implemented by the surgeon.

Steps 1420 and 1422 relate to adjustments made while the dynamic distractor is inserted. In a step 1420, data from the sensors is transmitted to a processing unit. In a non-limiting example, the processing unit is external to the dynamic distractor and sensors. As disclosed herein, the processing unit can be part of a notebook computer. The data from the sensors in the dynamic distractor can be displayed for viewing by the surgeon and medical team. In a step 1422, the surgeon can adjust the loading using soft tissue release techniques with the dynamic distractor in place. In one embodiment, the dynamic distractor can have a bellows or removable skirt around the periphery of the device that prevents debris from collecting within the interior. The bellows or removable skirt is removed to allow access along the medial and lateral periphery of the dynamic distractor and between the upper and lower support structures of the dynamic distractor. Further access for soft tissue release is provided by removing the handle of the dynamic distractor or positioning the handle away from the surgical area.

Steps 1424 and 1426 relate to adjustments made when parameters are measured in more than one region. In the knee example, measurements are made in the two knee compartments corresponding to the medial and lateral condyles in contact with the sensors. In a step 1424, the loading is measured in each compartment. In one embodiment, the measured loading in the two regions should be approximately equal. The differential loading can be measured and then adjusted if outside a predetermined differential load range. In general, the side measuring the higher loading is adjusted. In a step 1426, soft tissue release is performed to adjust the difference between the loadings measured in each compartment. As disclosed herein, the loading can be measured in real time as the release occurs. The loading is then adjusted until the difference between the compartments is within the predetermined differential load range thereby adjusting the joint towards the optimum based on measurement.

Steps 1428, 1430, 1432, 1434, 1436, and 1438 relate to positioning and aligning the leg using the dynamic distractor. In step 1428, the leg is positioned using position information provided by the dynamic distractor. In one embodiment, accelerometers in the sensors provide information on the angle of the tibia in relation to the femur. Thus, the leg can be put precisely in extension (e.g. a 180-degree angle between the femur and tibia) and in flexion (less than 180-degree angle, for example a 90 degree angle between the femur and tibia). In a step 430, the positional information can be sent to an external processing unit and the information displayed on a display for viewing by the surgeon. The surgeon can place the leg in extension or flexion to prepare or shape the proximal end of the tibia or the distal end of the femur. In steps 1432 and 1434, the surgeon identifies the mechanical axis of the leg. In one embodiment, one or more lasers are coupled to the handle of the dynamic distractor in the knee joint. As mentioned previously, the handle of the dynamic distractor is located overlying the center of the knee. In the step 1432, a first laser emits a signal to a first target that is positioned proximally to the center of the ankle. The line from center of the ankle to the center of knee aligns with the mechanical axis of the leg. The first target is positioned where it overlies the mechanical axis on a plane corresponding to the beam from the first laser. Similarly, in a step 1434, a second laser emits a signal to a second target that is positioned proximally to the center of the femoral head. A straight line from the center of the femoral head through the center of the knee to the center of the ankle comprises the mechanical axis of the leg. The second target overlies the mechanical axis and is positioned on a plane corresponding to the beam from the second laser. The surgeon can then measure the misalignment of the leg to the mechanical axis and make corrections appropriately.

FIG. 15 is an exemplary method 1500 for distracting surfaces of the muscular-skeletal system in extension and in flexion in accordance with an exemplary embodiment. The method can be practiced with more or less than the number of steps shown and is not limited to the order shown. In a step 1502, a distractor is placed between surfaces of a muscular-skeletal system. As mentioned previously, the distractor can be broadly used on the muscular-skeletal system including but not limited to the spinal column, knee, hip, ankle, shoulder, wrist, articulating, and non-articulating structures. As disclosed above, the distractor comprises a lift mechanism between a first support structure and a second support structure. In one embodiment, a handle couples to the lift mechanism to rotatably raise and lower the lift mechanism thereby changing a gap between the surfaces of the support structures. In general, the first and second supports structures are placed between two surfaces of the muscular-skeletal system. In a non-limiting example, to illustrate the principal, the distractor can be used in joint repair or replacement surgery to separate bones comprising the joint as they are prepared for an implant. Examples are vertebrae of the spinal column, the distal end of the femur and the proximal end of the tibia of a knee joint, or the pelvis and the proximal end of the femur of the hip.

In a step 1504, the gap provided by the distractor is changed and the muscular-skeletal system is placed in a first relational position. The gap of the distractor can be changed under the control of the surgeon thereby changing the spacing between the two surfaces of the muscular-skeletal system being distracted. In one embodiment, the gap corresponds to a thickness of one or more components to be implanted in the muscular-skeletal system. The distractor is likely to be initially placed between the two surfaces having a minimum gap and then expanded to a predetermined height or thickness. The muscular-skeletal system is placed in a first relational position with the distractor inserted between the two surfaces. The first relation position corresponds to the positions of the surfaces and portions of the muscular-skeletal system attached thereto.

In a step 1506, at least one parameter is measured with a sensor. The muscular-skeletal system is in the first relational position when parameter is measured by the sensor. In one embodiment, the distractor includes a sensor for measuring a parameter. For example, the sensor can provide accurate measurements of parameters such as distance, weight, strain, pressure, wear, vibration, viscosity, and density that relate to the procedure being performed. The distractor further provides two or more surfaces in contact with the muscular-skeletal system for close proximity measurement by the sensor. As disclosed hereinabove, the sensor can be self contained in a housing, can be placed in a cavity on one or more of the distracting surfaces and includes an exposed surface that can couple to the muscular-skeletal system for sensing.

In a step 1508, the muscular-skeletal system is repositioned to a second relational position. In a non-limiting example, the second relational position corresponds to movement of the distracted surfaces and portions of the muscular-skeletal system attached thereto in relation to one another. The position of the distracted surfaces in the second position is different from the position of the distracted surfaces in the first position. The distractor remains in place during positioning to the second relational position. This provides the benefit of reducing surgical time and stress on the patient. In general, the support structures of the distractor and more specifically the surfaces of the support structure allow natural movement of the muscular-skeletal in a normal range of motion.

In a step 1510, at least one parameter is measured by the sensor while in the second relational position. In one embodiment, the distractor remains in place while the measurement is taken. The surgeon or medical staff can compare measurement data with the muscular-skeletal system in two different positions. Often the measurement data will be similar throughout the range of motion or differ by a known amount due to geometrical differences of the position. Referring to a step 1518, the sensor can include a transmitter for transmitting measurement data from the sensor to a processing unit. The processing unit can be a logic circuit, digital signal processor, microcontroller, microprocessor, or analog circuitry. The processing unit can be part of a larger system such as a multi-component custom system or a commercially available notebook computer or personal computer. In a step 1520, the measurement is displayed on a display. The data can be processed by the processing unit and a GUI (graphical user interface) integrated with the display to present the data, enhance use of the data, interpret the data, and contemplate or detail corrections that may be needed to be made based on the data. The transmission of the data can occur as measurements over a range of motion and at least in the first relational position and the second relational position. In one embodiment, the distractor provides measurement data on the amount of distraction or gap produced by the device. This measurement data can also be transmitted along with the relational position data of the muscular-skeletal system. Thus, the distractor provides the benefit of measurement data being taken with the sensor at different points of the range of motion and at different gap heights without being removed.

In a step 1512, the sensor is placed on a surface of the distractor. In one embodiment, the sensor is a disposable device. The support structures of the distractor can have one or more recesses or cavities for receiving a sensor on a surface of the device. In particular, a cavity can be formed on a major surface of a support structure that comes in contact with a surface of the muscular-skeletal system during distraction. In a non-limiting example, one or more sensors are placed in one more cavities prior to insertion between the two surfaces of the muscular-skeletal system. The sensors are activated and in communication with the processing unit for taking measurements on the muscular-skeletal system. In a step 1514, the sensor is coupled to a surface of the muscular-skeletal system. As disclosed herein, the sensor can include a major surface that is exposed and substantially parallel to the major surface of a support structure. The sensor comes in contact with the muscular-skeletal system as the two surface of the muscular-skeletal system are distracted. Typically, as distraction increases a compressive force by the two surfaces of the muscular-skeletal system is applied to the two support structures placing the sensor in intimate contact with the surface. Alternatively, the sensor can be located on or in proximity to the distractor if direct contact is not required for the measurement.

In a step 1522, the alignment of at least one of the first or second relational position is compared to a mechanical axis of the muscular-skeletal system. Typically, the muscular-skeletal system has optimal alignments that maximize performance of the structure. The distractor can be used to measure misalignment to the mechanical axis. The distractor utilizes at least one of the surface being distracted to measure the misalignment. The distracted surface of the muscular-skeletal system has a geometric relationship with the mechanical axis. For example, the plane of the distracted surface can be a specific angle from the mechanical axis. Moreover, there can be specific landmarks of the surface that such as a center point that further identify the relationship with the mechanical axis.

In one embodiment, a plane of a portion of the surface of the distractor is co-planar with the muscular-skeletal surface it is contacting. This relationship is extended to a handle of the distractor where a surface of the handle is co-planar to the distracted surface of the muscular-skeletal system. The handle can also extend from muscular-skeletal system at a location corresponding to a landmark that corresponds to the mechanical axis. For example, it can extend centrally or at a specific position from the distracted surface. As disclosed hereinabove, a drop rod can be attached to an opening in the handle to visually and subjectively determine if alignment is within a predetermined range. The drop rod can also be coupled to other fixtures coupled to different areas of the muscular-skeletal system to measure alignment. Alternatively, one or more lasers can be attached to the handle of the distractor. The lasers are directed to one or more targets that are located along the mechanical axis. The amount of misalignment can be measured by the location where the beam hits a scale on each of the target.

In a step 1524, the muscular-skeletal system is modified to reduce the measured misalignment. In general, there will be an acceptable range for misalignment to the mechanical axis. Adjustments are made to reduce the error if the measurement is outside the acceptable range. Modifications to the muscular-skeletal system can take many forms. Material can be added or removed from the bone structure. Soft tissue release of the muscles, tendons, and ligaments can also be used to modify alignment. Additionally, other structures and materials that are both biological and artificial can be used to change or be added to the muscular-skeletal system to bring the two surfaces into alignment. After the modifications are performed, the alignment can be rechecked to verify that the misalignment error is with an acceptable range.

In a step 1526, the handle is used to direct the placement of the distractor between the two surfaces of the muscular-skeletal system. The handle of the distractor provides an external means for the surgeon to locate and position the first and second support structures of the distractor accurately in the muscular-skeletal system. In one embodiment, the handle is coupled to a lift mechanism that generates the gap between the first and second support structures. In a step 1528, the gap height can be varied using the handle. The handle is coupled to a shaft of the lift mechanism. In a non-limiting example, the handle is rotated to increase or decrease the gap of the distractor.

In a step 1530, the handle is moved away from the surgical area. The distractor is designed to provide access to areas in proximity to the two surfaces being distracted by the device. One access area is anterior to the two surfaces of the distracted muscular-skeletal system. Access is desirable to perform a surgical procedure or other step with the distractor in place. A benefit of the distractor is that the handle is hinged allowing it to be moved away from the area where the surgical procedure is being performed. Alternatively, in a step 1536, the handle is removed from the distractor also giving unobstructed anterior access. The distractor also has peripheral access and access between the first and second support structures when a gap is created. In one embodiment, the distractor has a bellows like skirt around the periphery of the device that is inserted between the two surfaces of the muscular-skeletal system. The skirt prevents materials or debris from the procedure from getting between the first and second support structures of the distractor. The skirt can be removed when a procedure is performed requiring anterior, posterior, medial, or lateral access. Alternatively, the periphery can be open and the interior space between the first and second support structures can be cleaned periodically to prevent build up of debris. The distractor provides open space anterior, posterior, medially, laterally, and between the first and second support structures allowing the surgeon great latitude in performing surgical procedures in proximity to the distracted area.

In a step 1532, the muscular-skeletal system is modified in the first relational position. As disclosed above, modifications to the muscular-skeletal system can take many forms. Bone modification, soft tissue release, implants, adding artificial or biological materials are but a few of the modifications that can be made using the access provided by the distractor. Similarly, in a step 1534, the muscular-skeletal system is modified in the second relational position. In one embodiment, the distractor is not removed during sensor measurement, movement through a range of motion, and during the modification process thereby greatly reducing the surgical time. Moreover, sensors in the distractor can provide real time measurement of how the modifications are affecting the distracted region. This instant feedback and quantitative measurement allow fine adjustments to be made that will greatly increase the consistency of orthopedic surgical procedures.

FIG. 16 is an exemplary method 1600 for distracting surfaces of the muscular-skeletal system in extension and in flexion in accordance with an exemplary embodiment. The method can be practiced with more or less than the number of steps shown and is not limited to the order shown. Steps 1602, 1604, and 1606 are respectively similar to steps 1502, 1504, and 1506 of FIG. 15 and are not described here for brevity. In a step 1608, the measured parameter is changed through modification of the muscular-skeletal system. As mentioned previously, the distractor can be broadly used on the muscular-skeletal system including but not limited to the spinal column, knee, hip, ankle, shoulder, wrist, articulating, and non-articulating structures. In one embodiment, the measurement and the modification of the muscular-skeletal system occurs with the distractor in place and the leg in extension.

In a step 1610, the muscular-skeletal system is repositioned to a second relational position. As mentioned previously, the position of the distracted surfaces in the second position is different from the position of the distracted surfaces in the first position. The distractor remains in place during positioning to the second relational position. This provides the benefit of reducing surgical time and stress on the patient. In general, the support structures of the distractor and more specifically the surfaces of the support structure allow natural movement of the muscular-skeletal in a normal range of motion.

In a step 1612, at least one parameter is measured by the sensor while in the second relational position. In a step 1614, the measured parameter is changed through modification of the muscular-skeletal system. The modification occurs with the muscular-skeletal system in the second relational position. In one embodiment, the distractor remains in place while moving the muscular-skeletal system to the second relational position, during sensor measurement, and modification of the muscular-skeletal system. The surgeon or medical staff can compare measurement data with the muscular-skeletal system in at least two different positions. Referring to a step 1628, the sensor can include a transmitter for transmitting measurement data from the sensor to a processing unit. In a step 1630, the measurement is displayed on a display. For example, the processing unit can be the microprocessor of a notebook while the display is the screen of the notebook. The data is transmitted in real time when a measurement is taken. In other words, the data is transmitted, processed, and displayed during the measurement and subsequent modification of the muscular-skeletal system in the first relational position. Similarly, the data is transmitted, processed, and displayed during the measurement and subsequent modification in the second relational position. The transmission of measured data can sent wirelessly using a radio frequency signal.

In a step 1522, the alignment of at least one of the first or second relational position is compared to a mechanical axis of the muscular-skeletal system. Typically, the muscular-skeletal system has optimal alignments that maximize performance of the structure. The distractor can be used to measure misalignment to the mechanical axis. The distractor utilizes at least one of the surface being distracted to measure the misalignment. The distracted surface of the muscular-skeletal system has a geometric relationship with the mechanical axis. For example, the plane of the distracted surface can be a specific angle from the mechanical axis. Moreover, there can be specific landmarks of the surface that such as a center point that further identify the relationship with the mechanical axis.

In one embodiment, a plane of a portion of the surface of the distractor is co-planar with the muscular-skeletal surface it is contacting. This relationship is extended to a handle of the distractor where a surface of the handle is co-planar to the distracted surface of the muscular-skeletal system. The handle can also extend from muscular-skeletal system at a location corresponding to a landmark that corresponds to the mechanical axis. For example, it can extend centrally or at a specific position from the distracted surface. As disclosed hereinabove, a drop rod can be attached to an opening in the handle to visually and subjectively determine if alignment is within a predetermined range. The drop rod can also be coupled to other fixtures coupled to different areas of the muscular-skeletal system to measure alignment. Alternatively, one or more lasers can be attached to the handle of the distractor. The lasers are directed to one or more targets that are located along the mechanical axis. The amount of misalignment can be measured by the location where the beam hits a scale on each of the target.

In a step 1616, the misalignment of the muscular-skeletal system is measured. As disclosed above, the measurement can be made using lasers and targets respectively coupled to the handle of the distractor and located along the mechanical axis of the muscular-skeletal system. In one embodiment, the misalignment is referenced to at least one of the two surfaces being distracted by the distractor. The alignment of the surface of the muscular-skeletal system is compared to the mechanical axis. In a step 1618, the muscular-skeletal system is modified to reduce the measured misalignment. As mentioned previously, there is an acceptable range for misalignment to the mechanical axis. Adjustments are made to reduce the error if the measurement are outside the acceptable range. In one embodiment, the corrections can be checked in real time as the modifications are made to see that the changes to the muscular-skeletal system are moving the misalignment error to the acceptable range.

In a step 1620, the sensor measures load. In one embodiment, the two surfaces of the muscular-skeletal system place a compressive force across the first and second support structures of the distractor. One or more sensors on the first and second support structures of the distractor can be used to measure loading and the distribution of loading. In a step 1622, the handle of the distractor is moved away from a surgical area. In non-limiting example, the surgical area corresponds to a region where muscles, tendons, and ligaments couple the at least two surfaces of the muscular-skeletal system together. The handle is moved to a position such that modification to the soft tissue can take place. In a step 1624, soft tissue is cut in the surgical area to reduce loading applied by the two surfaces of the muscular-skeletal system on the distractor. In general, the sensor can measure load, pressure, or force. The distractor provides access for the surgeon to make cuts to the soft tissue with the area distracted. The sensor measures in real time allowing the surgeon to adjust the load to an optimal value. In a step 1626, the handle can be removed to further improve the anterior access.

FIG. 17 is an exemplary method 1700 for distracting surfaces of a knee joint in extension and in flexion in accordance with an exemplary embodiment. The method can be practiced with more or less than the number of steps shown and is not limited to the order shown. A knee joint implant procedure of the muscular-skeletal system is used to illustrate the process of distraction. The knee joint comprises the distal end of the femur and the proximal end of the tibia. An artificial knee joint comprises a femoral implant, an insert, and a tibal implant. The femoral implant is shaped similar to and replaces the natural condyles at the distal end of the femur. The insert has a bearing surface for receiving the condyles and an inferior surface that mates and is retained by the tibial implant. In general, the artificial knee joint mimics the natural knee joint in operation once implanted.

All the steps for preparing a knee will not be disclosed for brevity but are well known by one skilled in the art. The knee is opened by incision to expose the distal end of the femur and the proximal end of the femur. The patella is removed or moved away from the knee joint region. The proximal end of the tibia is prepared by cutting the bone. In one embodiment, the proximal end of the tibia is prepared having a planar surface. In one embodiment, the planar surface is cut perpendicular to the mechanical axis of the leg. The distractor is then inserted into the knee joint.

The distractor has a first support structure having a superior surface for receiving the condyles of the femur and a second support structure having an inferior surface for mating to the prepared tibial surface. The shape of the support structures as disclosed herein allows natural movement of the leg through the range of motion with the distractor in place. In one embodiment, two sensors are placed in the superior surface of the distractor for measuring load in each compartment of the knee. A handle is used to direct the first and second support structures into the knee. The handle can be rotated to increase the gap of the distractor to place the superior surface of the first support structure in contact with the condyles of the femur and the inferior surface of the second support structure in contact to the tibial surface. More specifically, each condyle will contact a surface of a corresponding sensor.

In a step 1720, the alignment of a surface of the distractor is compared to the mechanical axis of the leg. The surface of the distractor corresponds to a surface of the knee. In one embodiment, the surface is the prepared surface of the tibia. Targets for leg alignment can be placed overlying the mechanical axis of the leg. Typically one target is placed in the ankle or foot region and a second target is placed in the hip joint region near the femoral head. The mechanical axis is a straight line from the center of the femoral head through the center of the knee joint to the center of the ankle. In one embodiment, handle extends from the knee joint at a point that corresponds to the center of the knee joint. The inferior surface of the second support structure is planar to the tibial surface. Similarly, one or more surfaces of the handle of the distractor is aligned to the inferior surface of the second support structure thereby being co-planar to the tibial surface. As disclosed hereinabove, lasers can be attached to the handle pointing towards the ankle target and the hip target. As mentioned previously, the tibial surface is prepared to be 90 degrees from the mechanical axis of the leg. Misalignment from the mechanical axis can be measured from where the beam of the laser hits the target. A correctly aligned leg will hit each target at a point representing the location of the mechanical axis. In a step 1722, the measured misalignment can be reduced through modification of the muscular-skeletal system. The modification can be to the bone, soft tissue, additional implants or materials (artificial and biological) that bring the femur and tibia into alignment with the mechanical axis.

In a step 1702, the knee joint is distracted with the leg in extension. The leg is in extension when the femur and tibia are positioned having a 180-degree angle between them. A handle of the distractor directs the support structures into the knee joint area. The handle is rotated to increase a gap between the superior and inferior surfaces until contact is respectively made to the condyles of the femur and the surface of the tibia. The sensors in each compartment of the first support structure are in communication with an external processing unit. In one embodiment, each condyle of the femur is in contact with a corresponding sensor surface throughout the range of motion of the leg. The surgeon positions the distractor such that the handle corresponds to the center of the knee joint, which aligns with the mechanical axis of the leg. In a non-limiting example, the leg alignment to the mechanical axis can be measured and corrections made to reduce misalignment if outside an acceptable range.

In a step 1704, a load is measured with the leg in extension for at least one compartment of the knee. The data is received by the processing unit and displayed on a display. For example, accelerometers in the sensors can show relative position of the femur to the tibia. In one embodiment, the femur and tibia are shown on the display to provide visual information to the surgeon on positioning. The angle between the femur and tibia can be displayed as well as alignment of the leg to the mechanical axis. The sensors include a measurement device such as a strain gauge to measure load. A complete knee replacement will measure loading on both compartments of the knee.

The distractor provides quantitative data that is used by the surgeon to prepare the knee. In a non-limiting example, the knee is distracted to a gap that corresponds to a combined insert and tibial implant thickness (the distal end of the femur is unprepared in the example). As is known by one skilled in the art, inserts are available in different sizes and thicknesses. The surgeon picks a size that is best adapted for the patient bone dimensions. The surgeon prepares the bone surfaces for an approximate combined thickness of the implants. For illustration purposes a combined implant thickness of 20 millimeters could be used. Typically, several insert thicknesses are suitable based on the tibial cut and the resulting gap between the tibial surface and the condyles of the femur. The sensor measurements are used to select an appropriate range and allows fine-tuning of the loading to within a very accurate range. For the full joint replacement, the gap height of the distractor, angle between tibia/femur (180 degrees, leg in extension), the loading on each compartment at the gap height, and the differential loading between the compartments is transmitted and displayed for viewing by the surgeon.

In a non-limiting example, the surgeon may have to increase or decrease the gap height of the distractor depending on the sensor readings. The increase or decrease in gap height will correspond to an available insert thickness. In one embodiment, the surgeon adjusts the gap height to measure load on the high side of a predetermined load range for each compartment. Selecting on a high side reading allows for fine adjustments to the final load value in a subsequent step. In general, the surgeon selects the appropriate insert size for the knee implant.

In a step 1706, the leg is moved into flexion while the distractor remains in the knee joint. As mentioned previously, the distractor provides surfaces that allows movement of the joint through the natural range of motion. This provides the benefit of being able to prepare the leg for load, balance, and alignment in more than one position using a single device. In one embodiment, the gap height of the distractor remains in the selected height for the leg in extension. Alternatively, the gap height of the distractor can be reduced while moving the leg in flexion to a final position and then readjusting the gap. In a non-limiting example, the leg is moved in flexion to a position where the femur and tibia form a 90-degree angle. In one embodiment, the surgeon can move the leg while viewing femur/tibia angle on the screen to get it precisely positioned.

In a step 1708, the load in at least one knee compartment is measured with the leg in flexion. In a non-limiting example, the gap height of the distractor in flexion is equal to the gap height selected by the surgeon when the leg was in extension. The sensors communicate with the processing unit providing the measured load in each compartment, differential loading between compartments, and the gap height to the surgeon with the leg in flexion. Thus, the leg can be moved from extension to flexion with the distractor in place. The sensors can measure load and differential loading in different positions and gap heights that can be displayed on a screen for the surgeon to view. The data is also stored in memory for use.

In a step 1710, the handle of the distractor is moved from a surgical area with the leg in extension. As mentioned previously, the handle of the distractor includes a hinge to position the handle away from a surgical area or can be removed to have anterior access to the distracted area. The surgical area corresponds to the muscle and ligaments coupling the femur to the tibia. The muscle and ligaments in the surgical area are located laterally and medially around the knee joint. A space is typically opened between the first and second support structures when the knee joint is distracted. Thus, the distractor enables soft tissue release by providing access from multiple vantage points to the muscle and ligaments with the device in place.

In a step 1712, the load in at least one compartment of the knee is reduced with the leg in extension. The handle is positioned to allow anterior and peripheral access to the soft tissue for incision. The surgeon can also place a scalpel between the first and second support structures for an interior or peripheral cut to the soft tissue if needed. In a non-limiting example, the soft tissue release can be performed when the leg is in extension after the loading is measured and the gap adjusted to a height selected by the surgeon. The soft tissue release can be performed on either the lateral or the medial sides of the knee or on both sides. In one embodiment, the soft tissue release is performed to bring each compartment loading within a predetermine loading range. The sensor data is transmitted, processed, and displayed in real time allowing the surgeon to view the actual measured effect of each cut on the loading in both compartments.

Referring to a step 1714, the load, force, or pressure in both knee compartments are measured with the leg in extension. In a step 1716, the measured load in each compartment is compared and a differential loading is calculated. In a step 1718, the differential loading between the two knee compartments is reduced using soft tissue release with the distractor in the knee joint. The surgeon can fine-tune the leg in extension to balance the loading between compartments with the distractor in place. In one embodiment, the surgeon can reduce the measured load on the side reading the highest value and bring the differential loading down within a predetermined differential loading range. In the example, the absolute loading measured in each compartment has also been reduced within a predetermined acceptable load range. As previously disclosed, the gap generated by the distractor corresponds to an available thickness insert of the artificial knee joint. The display can provide indicators to the surgeon when the measured load or the differential load is within their respective appropriate ranges.

In a step 1722, the handle of the distractor is moved from a surgical area with the leg in flexion. As mentioned previously, the leg is positioned with the femur and tibia at a right angle. In a step 1724, the load in at least one compartment of the knee is reduced with the leg in flexion. The handle is positioned to allow anterior and peripheral access to the soft tissue for incision. The surgeon can also place a scalpel between the first and second support structures for an interior or peripheral cut to the soft tissue if needed. In a non-limiting example, the soft tissue release can be performed when the leg is in extension after the loading is measured and the gap adjusted to a height selected by the surgeon. The soft tissue release can be performed on either the lateral or the medial sides of the knee or on both sides. In one embodiment, the soft tissue release is performed to bring each compartment loading within a predetermine loading range. The sensor data is transmitted, processed, and displayed in real time allowing the surgeon to view the actual measured effect of each cut on the loading in both compartments with the leg in flexion.

In a step 1726, the load, force, or pressure in both knee compartments are measured with the leg in flexion. In a step 1728, the measured load in each compartment is compared and a differential loading is calculated. In a step 1730, the differential loading between the two knee compartments with the leg in flexion is reduced using soft tissue release with the distractor in the knee joint. The surgeon can fine-tune the leg in extension to balance the loading between compartments with the distractor in place. In one embodiment, the surgeon can reduce the measured load on the side reading the highest value and bring the differential loading down within a predetermined differential loading range. In the example, the absolute loading measured in each compartment has also been reduced within a predetermined acceptable load range. As previously disclosed, the gap generated by the distractor corresponds to an available thickness insert of the artificial knee joint. In the non-limiting example, the gap created by the distractor in extension and flexion is the same. The display can provide indicators to the surgeon when the measured load or the differential load is within their respective appropriate ranges when the leg is in flexion. The surgeon can take further measurements on load and balance by moving the leg in different positions of flexion and recording the values. Further adjustments could be made to refine load and balance in these other flexion positions with the distractor in place.

FIG. 18 is an exemplary method 1800 to place the muscular-skeletal system in a fixed position for bone shaping in accordance with an exemplary embodiment. The method can be practiced with more or less than the number of steps shown and is not limited to the order shown. A spacer is a device that as it names implies spaces two surfaces apart from each other. A spacer can have a fixed height or can be variable. In one embodiment, a spacer has an inferior surface and a superior surface for coupling to surfaces of the muscular-skeletal system. A spacer with a fixed height is also known as a spacer block in the orthopedic field. A spacer having variable height is known as a distractor.

In a step 1802, a spacer is placed between two surfaces of the muscular-skeletal system. The spacer separates the two surfaces of the muscular-skeletal system. In one embodiment, the spacer is placed between two bones. The superior surface of the spacer couples to a surface of a first bone and the inferior surface couples to a surface of a second bone. There can be other material or components between the superior and inferior surface of spacer and the bone surfaces. Thus, the spacer separates the first and second bone surfaces by at least the height of the spacer.

In a step 1804, a cutting block is coupled to an exposed portion of one of the two bone surfaces. A cutting block is a template for shaping a bone surface. It is typically fastened to a bone surface and can have slots and openings for guiding surgical tools such as a bone saw. In one embodiment, a cutting block is used to shape a bone end for receiving one or more artificial implant components or material. In many cases, the position of the cutting block is not arbitrary but has to have precision alignment. For example, when performing a joint replacement, the cutting block has to be positioned having one or more alignments to the muscular-skeletal system. Misalignment can cause joint failure and premature wear. An illustration of alignment will be disclosed in more detail by example hereinbelow.

In a step 1806, the spacer is coupled to the cutting block to rigidly position the two surfaces in a predetermined position. Cutting blocks are typically designed to be used to shape the bones with the two surfaces and more specifically the bones having the surfaces in a specific position and alignment. In one embodiment, the spacer is fixed in position to at least one of the bone surfaces. The spacer can be under compressive force due to muscle, ligaments and tendons coupling the first and second bones together. Alternatively, the spacer can be temporarily attached to one of the surfaces. For example, a surgical screw or pin can be used to fix the spacer position. If the spacer is a distractor, the compressive force can be adjusted by increasing or decreasing the height between the superior and inferior surfaces. The spacer can allow the two bones to move in relation to one another in a natural range of motion without movement of the device to the bone surface. The spacer and the cutting block are couple together to prevent movement of the first bone, second bone, bone surfaces, and cutting block. Coupling the spacer to the cutting block stabilizes the cutting block and keeps the first and second bones in a fixed relation to one another while the bone surface is shaped.

In a step 1810, the misalignment of at least one of the surfaces is measured in relation to a mechanical axis of the muscular-skeletal system. In general, alignment of the muscular-skeletal system is critical to obtain optimal performance and longevity. In fact, many problems that end up requiring surgery are due to misalignment or deformity that causes premature wear or damage to the muscular-skeletal system that can directly or indirectly result in a disability or health problem. Implanted devices and artificial joints follow similar constraints from a geometric standpoint since many mimic the natural device. Thus, the surgeon needs affirmation that the alignment of the muscular-skeletal system while modifying bone and soft tissue to receive implanted components. Typically, at least one of the bone surfaces has a relationship with a mechanical axis of the muscular-skeletal system. The mechanical axis is an optimal alignment of the bone or bone surface to another portion of muscular-skeletal system. In a non-limiting example, the bone surfaces and the thus the bones having the bone surfaces have an optimal alignment. This optimal alignment is known as the mechanical axis.

In one embodiment, a surface or feature of the handle corresponds to a surface of the muscular-skeletal system. This relationship can be used to compare the orientation of the surface or feature to a mechanical axis. The superior or inferior surface of the spacer couples to the surface (or reference surface). The surface of the spacer is shaped similarly to the reference surface. For example, if the reference surface of the muscular-skeletal system is planar, the spacer surface is also made planar and has a relational position of being co-planar or parallel to the reference surface. A feature or the surface of a feature such as an opening, recess, mounting structure can have a specific orientation to the reference surface. For example, an opening can have an orientation that is perpendicular to the reference surface. Thus, the opening will extend in a direction approximately perpendicular to the muscular-skeletal reference surface on which the spacer is coupled. The handle can have one or more surfaces or features made to have specific relational positions to one or both of the spacer surfaces. For example, at least one surface of the handle can be made co-planar to the spacer surface corresponding to the muscular-skeletal reference surface. The surface on the handle can be used to create features that have specific positional relationships to the plane of the muscular-skeletal reference surface to aid in determining misalignment. Measurement of misalignment will be discussed in more detail hereinbelow.

As disclosed hereinabove, the mechanical axis can be defined by placing targets overlying the patient that align to the axis or to reference points of the body. For illustrative purposes, the leg in extension will be used to describe a mechanical axis of the muscular-skeletal system for a knee joint replacement. The mechanical axis of the leg in extension is a straight line from the center of the femoral head, to the center of the knee joint, and continuing to the center of the ankle. The targets are placed above the mechanical axis and typically near the ankle region and the center of the femoral head. In one embodiment, the handle is aligned with the center of the knee joint and extends vertically from the knee. In a non-limiting example, a feature such as a center of at least one opening or a recess in the handle is geometrically aligned to the knee center and corresponds to a point on the mechanical axis. The mechanical axis corresponds to a straight line from a point on the ankle target (e.g. ankle center), to a point on the handle, and extending to a point on hip target (e.g. center of femoral head). Extending a plane of the mechanical axis vertically (e.g. 90 degrees to the horizontal plane) with the leg in extension would intersect the center of the feature on the handle. In the example, the proximal end of the tibia is prepared by the surgeon as a flat surface. Ideally, the mechanical axis of the intersects the plane of the prepared tibial surface at a right angle. In a non-limiting example, lasers are coupled openings or recesses in the handle of the spacer. The lasers point towards the ankle target and the hip target. The lasers are pointed at a 90-degree angle from the plane of the prepared bone surface. Thus, misalignment can be measured from the targets as the difference angle between the point where beams hit the target and the identified point on each target corresponding to the mechanical axis.

In a step 1812 the muscular-skeletal system is modified to reduce the misalignment within a predetermined range. Once the misalignment is measured the surgeon can determine if modification to the muscular-skeletal system is required and what type of modification is suitable to reduce the error. In general, keeping the misalignment within a predetermined range will improve consistency of the surgery. Implant manufacturers can use the surgical data to determine the sensitivity of misalignment to rework, patient problems, and implant longevity.

In a step 1814 the spacer is aligned between the two surfaces where a handle of the spacer intersects the mechanical axis. Typically, the spacer alignment occurs before the misalignment to the mechanical axis is measured. As disclosed above, the spacer is part of an alignment system. The spacer has a predetermined position or alignment between the first and second bone surfaces and more specifically on the reference bone surface. In one embodiment, the handle extends from the spacer and intersects the mechanical axis. In the non-limiting example, the spacer is placed on the prepared tibial surface such that a superior surface of the spacer mates with the condyles of the femur. Moreover, the handle extends centrally from the spacer with the leg in extension corresponding to the center of the knee joint (e.g. a point on the mechanical axis).

In a step 1816, a rod is coupled to the handle. The handle has a known relational positioning to the mechanical axis within the predetermined range as described hereinabove. In one embodiment, the rod fits into an opening in the handle. The rod can be fastened to the handle. For example, portions of the rod and the opening in the rod can be threaded. Alternatively, the rod can be held in place by a powerful magnet, clamp, screw, or other means. In general, the rod is rigid and projects the positional relationship of the handle (e.g. the bone reference surface). In the knee example, the tibia and femur are placed in flexion. More specifically, the tibia and femur are positioned having a 90-degree angle between the bones. The cutting block is on the exposed portion of the distal end of the femur to be shaped. Thus, the entire distal end of the femur is not shaped in this position.

In a step 1818, the rod is coupled to the cutting block. The rod is then coupled to both the handle and the cutting block. In one embodiment, the cutting block has a channel approximately the same diameter as the rod. The rod is placed in the channel of the cutting block. The rod fixes the position of the spacer and the cutting block. As mentioned previously, the spacer and the handle is within a predetermine range of the mechanical axis. In a non-limiting example, the rod extends along the mechanical axis. Placing the rod into the channel aligns the cutting block to the mechanical axis. The rod fixes the relational position of the first bone surface to the second bone surface. In the embodiment, the femur and tibia are aligned to the mechanical axis and positioned perpendicular to each other.

In a step 1820, the gap of the spacer is changed. In one embodiment, the spacer is a dynamic distractor. The dynamic distractor includes sensors to measure loading. As the gap of the distractor is increased the first and second bone surfaces apply a compressive force on the spacer. The muscle, ligaments, and tendons couple the two bones holding them together under tension. The gap can be adjusted to be within a predetermined measured loading range (at the distracted gap height).

In a step 1822, the bone surface is shaped. The cutting block is used as a template to direct a saw blade to shape the bone. With the rod rigidly holding the bone surfaces in place the cutting block is stabilized and in alignment with the mechanical axis. In the knee example, the exposed portion distal end of the femur can be shaped with the leg in flexion. The shaped surface can receive an implant that will be aligned correctly to the mechanical axis as well as the femur and tibia surfaces.

FIG. 19 is an exemplary method 1900 of measuring the muscular-skeletal system in accordance with an exemplary embodiment. The method can be practiced with more or less than the number of steps shown and is not limited to the order shown. In a non-limiting example a spacer separates two surfaces of the muscular-skeletal system. The spacer has an inferior surface and a superior surface that contact the two surfaces. The spacer can have a fixed height or can have a variable height. The variable height spacer is known as a distractor. A handle extends from the spacer and typically resides outside or beyond the two surface regions. The handle is used to direct the spacer between the two surfaces. In one embodiment, the handle operatively couples to a lift mechanism of the distractor to increase and decrease a gap between the superior and inferior surfaces of the spacer. The spacer and handle is part of a system to measure alignment of the muscular-skeletal system. In one embodiment, at least one of the surfaces of the muscular-skeletal system that contacts the spacer has an optimal alignment to a mechanical axis of the muscular-skeletal system. The system measures the surface to mechanical axis alignment. In a non-limiting example, the surface can be corrected by a surgeon when the surface is misaligned to the mechanical axis outside a predetermined range.

A surface or feature of the handle has a relational position to the (reference or alignment) surface of the two surfaces that the spacer contacts. In one embodiment, the reference surface of the muscular-skeletal system is a planar surface. The surface of the spacer contacting the reference surface of is also planar and thus has the relational position of being planar or co-planar when coupled thereto. Similarly, the handle is attached or coupled to the spacer block or distractor having a relational position to the surface of the spacer that contacts the reference surface. Typically, the relational position of the surface or feature on the handle is co-planar or perpendicular to the surface of the spacer.

The two surfaces of the muscular-skeletal system are typically positioned in predetermined relation before measuring misalignment to the mechanical axis. The predetermined relation typically corresponds to a natural position of the muscular-skeletal system. For example, a common position is the tibia positioned 180 degrees from the femur, which is commonly known as a leg in extension. In this example, the reference surface is a proximal tibial surface of the tibia. In one embodiment, the proximal tibial surface is a planar surface prepared by the surgeon. Ideally, the tibial surface is formed perpendicular to the mechanical axis with the leg in extension. A measurement of the tibial surface to the mechanical axis is performed to verify that it is within a predetermined range or specification. Similarly, a measurement is often taken with the muscular-skeletal system in a second predetermined relation. The second predetermined relation is typically at a different point in the range of natural motion. For example, the leg in extension with the tibia positioned 90 degrees from the femur. One or more sensors such as accelerometers can be use to measure the relational positioning of the two surfaces of the muscular-skeletal system.

In one embodiment, a feature such as an opening or cavity is formed in the handle. The opening or cavity has a relational positioning to the reference surface when the spacer block or distractor is placed between the two surfaces of the muscular-skeletal system. In a non-limiting example to illustrate the relational positioning, the opening or cavity is perpendicular to the plane of the reference surface. In the example where the mechanical axis is ideally perpendicular to the reference surface a rod is placed in the opening or cavity. The rod is directed perpendicular to the plane of the reference surface. A comparison of the direction of the rod to the mechanical axis yields misalignment of the reference surface to the ideal. The surgeon can use the rod with landmarks that identify the mechanical axis to make a visual determination of alignment. Alternatively, the rod can be used to measure an angle difference between the mechanical axis and the actual muscular-skeletal alignment. Furthermore, the rod can include one or more sensors for measuring a parameter of the muscular-skeletal system including alignment.

In another embodiment, targets are placed on the muscular-skeletal system aligned with the mechanical axis. An axis point or axis line on the target aligns with the mechanical axis. A laser is placed in the opening or cavity on the handle. In a non-limiting example, the center of the opening or cavity corresponds to an axis point on the mechanical axis. The mechanical axis is a straight line between the center of the opening and one or more targets. The beam of the laser is directed to the target. Using the example above, the beam is directed perpendicular to the plane of the reference surface to the target. The position where the beam hits the target corresponds to misalignment of the reference surface to the mechanical axis. The misalignment results in the beam hitting the target on either side of the axis point or line. In a similar fashion the location of the beam on the target could also be used to determine if the reference surface has a slope by viewing where the beam hits the target in an opposite plane. For example, if the misalignment measurement is on a horizontal plane relative to the axis point, a slope of the reference surface can correspond to the beam location on a vertical plane or above/below the axis point.

In a step 1902, two surfaces of the muscular-skeletal system are distracted with a distractor. The gap between the two surfaces can be varied with the distractor. In a step 1904, an alignment aid is coupled to a handle of the distractor. The misalignment of a surface of the two surfaces to a mechanical axis is measured with an alignment aid that is coupled to a handle of the distractor. The alignment aid is coupled to a surface or feature of the handle of the distractor that has a relational position to the surface. In one embodiment, an alignment aid can be a laser and at least one target. Referring to a step 1926, at least one laser is coupled to the handle of the distractor. In one embodiment, the at least one laser is coupled to a feature such as an opening or cavity. In a step 1928, at least one target is coupled to the muscular-skeletal system. In general, the at least one target can be placed overlying the muscular-skeletal system such in a location corresponding to an axis point of the mechanical axis. An axis point on the target aligns to the mechanical axis. The beam from the laser hits the target. The point where the beam hits is compared to the axis point of the target that corresponds to the mechanical axis. The target can have a scale that measures misalignment of the surface to the mechanical axis. As disclosed above, the direction of the laser corresponds to the surface of the muscular-skeletal system.

In a step 1906, the two surfaces of the muscular-skeletal system are placed in a first position. The misalignment of the surface to the mechanical axis is measured. In a step 1908, the misalignment is corrected if the measurement is outside a predetermined range. In general, data generated by this system can yield significant information on how misalignment affects the muscular-skeletal system. The data can be used to further identify the optimal predetermined range that minimizes the effect of misalignment. In a step 1910, the gap or the space between the inferior and superior surfaces of the spacer is measured. In a step 1912, a force, pressure, or load applied by the two surfaces of the muscular-skeletal system on the distractor is measured. One or more sensors can be placed in the superior or inferior surfaces to measure a parameter such as but not limited to force, pressure, or load. The two surfaces of the muscular-skeletal system apply pressure or force to the superior and inferior surfaces of the spacer and more specifically on at least one sensor on either surface of the distractor. The measurements of steps 1908, 1910, and 1912 are completed with the muscular-skeletal system in the first position. As mentioned above, the first position is typically a geometrically significant position of the muscular-skeletal system that allows comparison to the mechanical axis. The measurement data is transmitted to a processing unit for viewing on a display and for long-term storage. The system allows for real time measurement if and when the muscular-skeletal system is modified with the distractor in place.

The following measurements steps are similar to the measurements in the first position described above. In a step 1916, the two surfaces of the muscular-skeletal system are placed in a second position. The misalignment of the surface to the mechanical axis can be measured in the second position to verify alignment. In a step 1918, the misalignment is corrected in if the measurement is outside a predetermined range. In a step 1920, the gap or the space between the inferior and superior surfaces of the spacer is measured. In a step 1922, a force, pressure, or load applied by the two surfaces of the muscular-skeletal system on the distractor is measured. The measurements of steps 1918, 1920, and 1922 are completed with the muscular-skeletal system in the second position. As mentioned above, the second position is also a geometrically significant position of the muscular-skeletal system that allows comparison to the mechanical axis. The measurement data is transmitted to the processing unit. The system allows for real time measurement in the second position.

FIG. 20 is an exemplary method 2000 of a disposable orthopedic system in accordance with an exemplary embodiment. The method can be practiced with more or less than the number of steps shown and is not limited to the order shown. In a step 2002, at least one parameter of the muscular-skeletal system is measured with a sensor. As disclosed hereinabove, the sensor provides accurate measurements of parameters such as distance, weight, strain, load, pressure, force wear, vibration, viscosity, and density. In one embodiment, the sensor is a disposable sensor. In a non-limiting example, the disposable sensor is adapted to an orthopedic device such as a tool or implantable component. The sensor is sterilized and placed in a package that maintains sterility. The sensor is typically contaminated with biological material when used to measure the muscular-skeletal system during a surgical procedure. In a step 2004, the sensor is disposed of after use. The sensor is disposed of as biological waste if contaminated by biological material during the procedure. Packaging of a single use device greatly reduces cost, as the housing does not have to withstand repeated cleanings. Moreover, it eliminates the cost of a sterilization process. In a non-limiting example, the sensor is used in orthopedic surgery and more specifically to provide intra-operative measurement during joint implant surgery.

In a step 2022, the sensor is powered. In one embodiment, the sensor is not powered until it is used. The sensor can have a temporary power source that powers the device for a procedure. A charger can be provided to charge the unit up prior to use. The power source can be internal to the sensor to prevent issues with sterility. The temporary power source can sustain the device for a predetermined period of time that is sufficient for the procedure but prevents reuse of the device. The sensor is in communication with a processing unit. In one embodiment, the processing unit is located external to the sensor. In the surgical example, the processing unit is located outside of the immediate surgical area. For illustration purposes, the processing unit is a microprocessor of a notebook computer.

In a step 2024, patient information is inputted to the processing unit. The patient information can input through a variety of methods. For example, the information can be typed in, scanned in, downloaded via radio frequency tag, or verbally transmitted, recorded, and converted. The patient information can be displayed on a screen of the notebook computer. The patient information can include personal, medical, and specific information related to the procedure.

In a step 2026, a reader is coupled to the processing unit. The reader can be wired or wireless. In a step 2028, the reader is used to scan in information pertaining to the procedure. In one embodiment, the reader is used to scan in components of the system such as the sensors, alignment aids, implant components, and other devices prior to use. In a non-limiting example, the information can be used for identification of the specific components (e.g. serial numbers) used during the procedure. The information can be used for billing, patient records, long term monitoring of components, and component recall.

In a step 2006, the sensor is placed between two surfaces of the muscular-skeletal system. The sensor measures a parameter in proximity to the surfaces of the muscular-skeletal system. In one embodiment, the two surfaces are exposed by incision. For example, the sensor has a small form factor allowing it to be placed in or on a spacer. A spacer separates the two surfaces of muscular-skeletal system. Examples of a spacer are a spacer block or a distractor. In a non-limiting example, a joint of the muscular-skeletal system is exposed. One or more of the joint surfaces can be shaped or prepared by the surgeon. The spacer block or distractor is placed between the joint surfaces of the muscular-skeletal system. The sensor can have an exposed surface that will contact at least one of the two surfaces.

In a step 2008, a load, force, or pressure applied by the two surfaces on the sensor is measured. For example, the spacer block or distractor distracts the joint of the muscular-skeletal system. A measurement of the load, force, or pressure is measured by the sensor for a spacing or gap. The gap is the distance between the two surfaces of the muscular-skeletal system. In a step 2016, a gap can be varied between the two surfaces of the muscular-skeletal system with the spacer in place. In one embodiment, the gap is varied by a distractor between the two surfaces. The distractor includes a lift mechanism that can increase or decrease a gap between the two surfaces. The sensor can measure one or more parameters at each gap height.

In a step 2010, the sensor is placed in a cavity of a surface of a spacer. In general, a spacer has a superior and inferior surface. The superior and inferior surfaces are placed between the two surfaces of the muscular-skeletal system. The superior and inferior surfaces come in contact with the two surfaces of the muscular-skeletal system under distraction. In one embodiment, one of the inferior or superior surfaces of the spacer have a cavity or recess for receiving the sensor. The sensor is placed in the cavity exposing a surface of the sensor. The surface of the sensor can be planar with the surface of the spacer. As disclosed above, the spacer can be placed between the two surfaces of the muscular-skeletal system such that the surface of the sensor is in proximity or in contact with one or both of the surfaces.

In a step 2012, the sensor is removed from the cavity or recess. The sensor can have a feature that simplifies removal from the superior or inferior surface of a device. For example, the sensor can have a tab, indentation, or surface feature that allows removal by hand or with a tool. Alternatively, the device in which the sensor is placed can have a mechanism to push the sensor out of the recess. In a step 2014, the sensor is disposed of after being removed from the cavity or recess.

In a step 2018, an alignment of a surface to a mechanical axis is measured with an alignment aid. In general, at least one of the two surfaces of the muscular-skeletal system has an alignment with a mechanical axis of the muscular-skeletal system. The alignment to the mechanical axis needs to be preserved or corrected during the procedure. Similar to the sensor above, components of the alignment aid are designed for a single use. In one embodiment, the mechanical axis is identified. Similarly, the surface of the muscular-skeletal system is compared to the mechanical axis. The difference between the mechanical axis and surface of the muscular-skeletal system is a measure of the misalignment. Adjustments to the muscular-skeletal system can be performed to reduce misalignment within a predetermined range. In a step 2020, at least one component of the alignment aid is disposed of after the procedure is completed.

FIG. 21 is an exemplary method 2100 of a disposable orthopedic system in accordance with an exemplary embodiment. The method can be practiced with more or less than the number of steps shown and is not limited to the order shown. In a step 2102, an alignment of a surface to a mechanical axis is measured with an alignment aid. In general, a mechanical axis is identified by the alignment aid. The mechanical axis is then compared to an alignment of one or more surfaces or structures of the muscular-skeletal system. Ideally, the difference or misalignment of the surfaces or structures to the mechanical axis should be within a predetermined range that places the surfaces or structures in an optimal muscular-skeletal kinematic setting.

In a non-limiting example, targets and more specifically a point on each target correspond to points on the mechanical axis. The targets are coupled to the muscular-skeletal system in proximity to the surfaces of the muscular-skeletal system. The surfaces can be part of structures of the muscular-skeletal system such as bones, muscles, ligament, tendons, and cartilage. The structures corresponding to the surfaces can have a relational positioning in 3D space that relate to the position of the surfaces to each other. In one embodiment, the surface is between the targets. Alternatively, the targets can be placed having an unobstructed path to the surface that allows measurement. The targets can also align having a more complex geometry to represent the mechanical axis. One or more lasers are mounted at a height where a beam from a laser will hit the target unless grossly misaligned. The laser is mounted having a predetermined positional relationship to the plane of the surface. For example, the laser is directed 90 from the plane of the surface corresponding to a direction of the mechanical axis. The targets can have calibration markings to indicate a measure of misalignment. The beam from the laser will hit the point on each target if the plane of the surface is aligned correctly to the mechanical axis. Conversely, the distance from the point on each target is representative of the misalignment. The calibration marking where the beam hits represents the misalignment. Adjustments to the muscular-skeletal system can be performed to reduce misalignment within a predetermined range. In a step 2104, at least one component of the alignment aid is disposed of after the procedure is completed. For example, the targets or lasers that are within the surgical field.

In one embodiment, the alignment is performed with a distractor between the two surfaces of the muscular-skeletal system. The distractor separates the surfaces of the muscular-skeletal system. In a step 2122, the two surfaces of the muscular-skeletal system are distracted when measuring alignment. The distractor can vary the gap between the two surfaces of the muscular-skeletal system allowing measurements to be taken with varying gap heights.

In a step 2106, at least one parameter of the muscular-skeletal system is measured with a sensor. As disclosed hereinabove, the sensor provides accurate measurements of parameters such as distance, weight, strain, load, pressure, force wear, vibration, viscosity, and density. In one embodiment, the sensor is a disposable sensor. In a step 2108, the sensor is disposed of after use. The sensor is disposed of as biological waste if contaminated by biological material during the procedure. A disposable sensor provides data for providing quantitative data on the procedure without the large capital expenditure required for traditional measuring equipment.

In general, data is collected relevant to the procedure. For example, patient information and component information can be collected and stored in an electronic format prior to the procedure being performed. Component information can relate to products used in the procedure such as serial number, date of production, model number, and other related data that identifies the product. In a step 2014, the sensor is powered. In one embodiment, the sensor is not powered until it is used. Once enabled, the sensor can establish communication with a processing unit. The processing unit can be a collection point for information. The processing unit is coupled to memory that can store information locally or send the information to a database. Similarly, the sensor can have information pertaining to the sensor product stored in memory. The sensor can send this information to the processing unit as part of the information collection process. In a step 2116, patient information is input and provided to the processing unit. The patient information can be input through a variety of methods. For example, the information can be typed in, scanned in, downloaded via radio frequency tag, or verbally transmitted, recorded, and converted. The patient and component information can be displayed on a screen coupled to the processing unit for use by the surgeon or other healthcare providers. The patient information can be encrypted to prevent access by unauthorized people. The patient information can include personal, medical, and specific information related to the procedure. In a step 2118, a reader is coupled to the processing unit. The reader can be wired or wireless. In a step 2120, the reader is used to scan in information pertaining to the procedure. In one embodiment, the reader is an alternate approach of data collection of components and information. The reader is used to scan and input information displayed on components or packaging of components. The information can be used for billing, patient records, long term monitoring of components, and component recall.

In a step 2110, data measured by the sensor is transmitted to the processing unit. The system dynamically measures a parameter of the muscular skeletal system. For example, the system can measure the parameter when the muscular-skeletal system is placed in different positions whereby the position of the surfaces also differs. Another example is modification of the muscular-skeletal system. The sensor reading adjusts as the modification of the muscular-skeletal system changes the parameter being measured. In a step 2112, the data is displayed in real time on the display. In one embodiment, the sensor transmits data as soon as a measurement is taken. The data is then processed by the processing unit and displayed in a format that aids the surgeon or healthcare worker. Thus, any change in the parameter is stored and displayed while the sensor is enabled.

FIG. 22 is a diagram 2200 illustrating a data repository and registry for evidence based orthopedics in accordance with at least one exemplary embodiment. In general, the life expectancy of the general population is increasing. It is well known that the body naturally degenerates over time due to the aging process. For example, as we get older there is a natural reduction in bone density and increased wear to the physical joints of the muscular-skeletal system. The situation is exacerbated by being physically active in the work environment, personal life, or both. The consequence of these combined factors is that muscular-skeletal issues are becoming more prevalent. Moreover, these issues can result in a reduction of a quality of life that will impact an increasing percentage of the population. This is evidenced by the high rate of growth of orthopedic surgeries and the implanted artificial orthopedic components.

As used hereinbelow, the term parameter corresponds to a measurement of the muscular-skeletal system. The measurement can comprise parameters that characterize the muscular-skeletal system such as temperature, pH, distance, weight, strain, pressure, force, wear, vibration, viscosity, and density to name but a few. The measurements can be taken on the natural muscular-skeletal system or artificial components used to replace portions of the system. As discussed herein, the measurements equally apply to natural and artificial components that comprise a muscular-skeletal system.

A data repository and registry 2214 is a database comprising dynamic data measured from the muscular-skeletal system of patients. In at least one exemplary embodiment, the data repository and registry 2214 comprises orthopedic parameter measurements of more than one patient. Dynamic data corresponds to measurements made to the muscular-skeletal system of the patient. The data measurements occur with little or no human intervention to simplify collection. The dynamic data can comprise measurement by sensors that periodically or by user control measure at least one parameter that is used to characterize the patient orthopedic health or integrity of the muscular-skeletal system (natural or artificial). Thus, in one embodiment, the term dynamic reflects that the measurements are not confined or constrained by time or place. The quantitative measurements can be used to provide continuous feedback by analysis of the data to the patient and healthcare provider. In at least one exemplary embodiment, the quantitative measurements are used to affect the patient outcome, which will be disclosed in more detail below. In a broader sense the data repository and registry 2214 will provide a transition to evidence based medicine in orthopedics. In a further embodiment, data repository and registry 2214 is used to determine efficacy of treatment, early warning of potential problems, improve future orthopedic devices, enhance health care efficiency, reduce orthopedic revisions, and reduce cost of orthopedic procedures.

In many cases, problems with the muscular-skeletal system for patients 2202 are not short term nor are solutions permanent. For example, an artificial joint or joint component has a life cycle that can measure a decade or more. This life cycle is best illustrated by example. Typically, a patient sustains significant pain and loss of mobility before undergoing an artificial joint implant. The physician and patient monitor the joint. The physician can utilize x-rays or cat-scans of the joint region to determine a source of the problem. At some point in time, a decision is made that it would be in the best interest of the patient to partially or totally replace a joint or joints. In general, a joint replacement is a highly invasive procedure requiring surgery that can include bone and tissue modification. Implant operations to the hip, knee, spine, shoulder, and ankle require interaction with a surgeon, surgical team, operating room and hospital. The patient requires a post-surgical convalescence and cannot immediately use the implanted joint. There are also post surgical complications such as infection and pain that require routine consultation with the surgeon, physician, and health care workers. After recovering from surgery, the patient goes through extensive rehabilitation to acclimate to the artificial joint and use it similarly to a normally functioning natural joint. Long term the patient can require physician visits to check joint status or continued therapy. A worst-case scenario is incorrect installation, joint failure, or un-noticed infection on the artificial surfaces of the joint. Each of these scenarios require substantial rework of the joint and places the patient under severe stress. The cost to the healthcare system to consult, repair, and rehabilitate is a substantial burden that will continue to grow as the number of implants increase. An additional factor is the fact that an increasing number of patients will require replacement of the joint some time in the future

A further point that should be noted is that each patient of patients 2202 is unique with different physical attributes. More specifically, the geometry of the muscular-skeletal system can have significant variations from patient to patient. Similarly, every surgeon is different and the components developed by the various orthopedic manufacturers will have variations from each other. At this time, orthopedic surgery relies on the skill of the surgeon's subjective knowledge of the procedure for determination on whether the fit of the components is correct. The surgeon often manipulates the joint to “feel” interaction of the implanted components to assess proper fit. Finally, joint wear or joint problems are a function of individual characteristics such as user kinematics, joint mechanical fit, how the joint used, and how much it is used. Thus, joint operation, maintenance, and failure analysis are a complex function of a wide variety of factors of which little or no information exists specifically to the patient.

Patients 2202 are one potential customer of provider 2210 that will benefit from having a history of quantitative measurements of their muscular-skeletal system. Patients 2206 are coupled 2204 for dynamic sensing 2206 at different times and locations. As mentioned previously, the sensors are placed in equipment, tools, and in orthopedic implants that are in proximity or intimate contact to the muscular-skeletal system such that they are coupled 2204 to perform a measurement. In a non-limiting example, parameters of the muscular-skeletal system of patients 2206 are measured by a physician, pre-operatively, intra-operatively, post-operatively, and can be monitored long term. Dynamic sensing 2206 can be periodic or under user control. For example, measurements are made during implantation of an artificial joint to provide quantitative measurements on the installation. Another example is monitoring bone density. Sensors can be implanted in the bone to monitor changes in bone density. Patients 2202 can couple the implanted sensors to a receiver device periodically to take measurements that are sent over the internet to appropriate resources for analysis. Similarly, a physician can have a sensor receiver or sensored equipment in a clinic or office for taking measurements during a patient visit. The ability to generate quantitative data can be used to alert patients 2202 if monitored changes indicate weakening of the bone (e.g. loss of bone density). Therapy can then be provided at an appropriate time to strengthen the bone before a fracture occurs. The measurements can also have significant value in evaluating the clinical efficacy of different types of treatment. Dynamic sensing 2206 can be incorporated into orthopedic devices, surgical tools, implanted, and in monitoring equipment.

Dynamic sensing 2206 comprises sensors having a form factor that allows integration into equipment, tools, and orthopedic implants. In one embodiment, the sensors are coupled to a processing unit and a display. The sensors are wired or wirelessly coupled to the processing unit. The processing unit can display the measured data in real time on the display and store the measured data in local memory. The processing unit can be coupled to the internet to send encrypted data. In one embodiment, the processing unit and display are separate from the sensors to minimize cost, power, and form factor. The cost to manufacture sensors can be lowered by high volume manufacturing. In one embodiment, volume can be achieved by providing single use sensors that can measure key parameters during installation of orthopedic implants. The surgeon uses the quantitative measurements of the sensors to install an orthopedic implant or to perform a procedure within certain measured predetermined values or ranges. For example, a tighter tolerance in alignment, load, and balance can be achieved through measurement resulting in more consistent procedures. The incremental cost of using the sensors is justified by the reduction in revision and post-operative complications. The sensors are disabled or disposed of after use in a measurement application such as orthopedic implant surgery. Orthopedic procedures and joint implants currently numbers in the millions each year with an increasing annual growth rate. Thus, providing a sustained high volume application that lowers sensor cost. Adoption of the low cost sensing would enable integration into tools and equipment for monitoring/measuring orthopedic health over an extended period of time thereby generating clinical data for an individual patient as well as across the orthopedic industry.

Dynamic sensing 2206 generates quantitative data on the muscular-skeletal system of patients 2202. The quantitative data is typically a physical measurement that is converted to electronic digital form and sent to a provider 2210 through a wired, optic or wireless coupling 2208. Provider 2210 can provide the sensors for measurement to facilitate dynamic sensing 2206 and data collection. In one embodiment, the data is sent through a wired or wireless connection from the sensors to a processing unit that is part of a computer system or equipment. The processing unit is typically located in proximity to dynamic sensing 2206. The processing unit can analyze and display the measurements in real time to the patient or healthcare provider. The processing unit can immediately send the measurement data of the muscular-skeletal system to data repository and registry 2214 or store it in memory to be sent at an appropriate time. The data can also include personal and medical information. The data is encrypted to maintain patient privacy and deter theft of the data. In the example, the measurement data, personal information, and medical information is transferred through the internet via a coupling 2208. The data is stored in data repository and registry 2214, which is a secure database through a wired, wireless, or optic connection 2212. Provider 2210 has rights to use, license, or sell the quantitative data and manages data repository and registry 2214. In one embodiment, provider 2210 provides the sensors directly or through original equipment manufacturers to measure parameters of the muscular-skeletal system.

Provider 2210 displays electronic digital information pertaining to measured parameters of the muscular-skeletal system. In one embodiment, the display can be a website. The website can be descriptions of the type of muscular-skeletal information that is available. A customer 2218 interacts with the website through a wired, optic, or wireless coupling 2216. The website can provide options of one or more services provided corresponding to the measured data in data repository and registry 2214. An example of a service is to collate or organize data based on specific criteria or performing an analysis on the data. The customer 2218 can request access to data repository and registry 2214. The request can comprise a service request or access to the measured data for customer proprietary use. The access to data repository and registry 2214 can be restricted or limited based on a number of criteria. As disclosed, patient information and medical history can be stored in data repository and registry. Similarly, the procedure, type of components, serial numbers, and manufacturer of the components can be part of the database. In many cases, the information is proprietary or protected such that access is restricted and specific procedures are put in place to receive the restricted information. As shown, patients 2202 can be customers 2218 and couple to data repository and registry 2214 through coupling 2220. Patients 2202 and physicians of patients would be a select group having access to specific and limited personal and medical information. Conversely, the measured data can be organized and provided anonymously for use by different entities such as hospitals, clinics, government, universities, and manufacturers to name but a few.

FIG. 23 is a diagram 2300 illustrating an orthopedic lifecycle approach to manage orthopedic health based on patient clinical evidence in accordance with at least one exemplary embodiment. The approach utilizes sensors that can measure parameters of the muscular-skeletal system automatically with minimal or no human intervention. The measurements can also be taken under user control. The measured parameters are sent to and stored in a data repository and registry. Measurements on the muscular-skeletal system include artificial components that have been implanted to replace or supplement the existing muscular-skeletal structure. The sensors are incorporated in tools, equipment, or are implanted in or in proximity to the muscular-skeletal system.

A customer 2302 utilizes measured parameter data of the muscular-skeletal system. In one embodiment, customer 2302 is a patient or health care provider such as a physician or surgeon. The patient or physician can both provide measured parameter data as well as access information from the data repository and registry. In general, quantitative measurements of the muscular-skeletal system are made over an extended period of time, as will be detailed hereinbelow. The measurements can be used to determine orthopedic health status and to indicate potential issues to a patient. In one embodiment, the measurements encompass an entire lifecycle of the patient including orthopedic implants and bone health. Sensored tools and instruments in the patient home, physician office, healthcare facility, hospital, or clinic are used to measure parameters of the muscular-skeletal system in a step 2304 of pre-operative sensing. The parameter measurements are converted to an electronic digital form by the tools or equipment. The measurement data is sent through a medium such as the internet where in a step 2310 of storing information in data repository and registry, the measurements are made part of the database. The measured data can include patient personal and medical information. The quantitative measurements supplement subjective information provided by the patient or physician on an issue of the muscular-skeletal system. In one embodiment, the measurements are displayed to the patient or physician in real time using the tool or equipment. Examples of quantitative measurements are alignment, range of motion, relational positioning, loading, balance, infection, wear, and bone density. This can be used with visual images of the muscular-skeletal system along with subjective information such as pain location to make an effective diagnosis. The measured data can provide an accurate assessment of the status of the muscular-skeletal system prior to any subsequent repair or reconstruction.

As disclosed above, the muscular-skeletal system can degrade to a point where it can substantial impact a patient quality of life. The decision is often made to repair or replace a portion of the muscular-skeletal system to reduce pain and increase patient mobility. The surgery typically takes place in the operating room of a hospital or clinic. In a step 2308, intra-operative sensing using sensored tools and equipment generates measured data related to the surgery and the installed implant. The sensored tools or equipment convert the measurements to an electronic digital form. The measurement data is sent through a medium such as the internet where in a step 2310 of storing information in data repository and registry, the measurements are made part of the database. The measured data can include patient personal and medical information. The quantitative measurements are displayed during the surgery to aid in the installation. The measurements allow the surgeon to fine tune the installation to be within predetermined ranges that are backed by clinical evidence from the data repository and registry that have proven to reduce negative outcomes. Thus, the parameter measurements supplement a surgeon's subjective skills to ascertain that components are optimally fitted to mimic natural muscular-skeletal operation.

In general, repair or reconstruction to the muscular-skeletal system includes artificial components. Sensors can be installed in proximity to the muscular-skeletal system, in the muscular-skeletal, or as part of the implanted components during surgery. Implanted sensors can be permanent or temporary. In a step 2308 of monitoring orthopedic health, sensors generate quantitative data on measured parameters of the muscular-skeletal system. Use of the quantitative data in conjunction with the subjective observations of the patient and healthcare providers can increase patient orthopedic health, prevent catastrophic situations, and reduce healthcare costs. In one embodiment, the implanted sensors are powered up temporarily in a manner that allows location independent measurements to be taken. For example, parameter measurements can be taken at the patient's home or at a healthcare provider facility. At home measurements provide an advantage of reducing physician visits while providing a regular status update to the patient and healthcare provider. In a non-limiting example, the patient has a receiver that enables the sensors for measuring parameters. Enabling the sensors comprises providing power and establishing a communication path between sensors and the receiver. The communication can be one-way or both transmit and receive. In one embodiment, the sensors transmit a low power signal. The receiver is placed in proximity to the sensors to receive the low power signal sent by the sensors. The sensors measure parameters of the muscular-skeletal system and convert the measurements to an electronic digital form. The sensors transmit the measurements in electronic digital form to the receiver. In the example, the receiver is coupled to a processing unit. The processing unit can display information to the patient or physician corresponding to the measurements or the status of the muscular-skeletal system. The processing unit sends the measurement data through a medium such as the internet where in a step 2310 of storing information in data repository and registry, the measurements are made part of the database. The measurement data can include patient personal and medical information. A notice, analysis, or report can also be generated by the processing unit or by the data repository and registry. The report can be sent to the appropriate people via a medium such as the internet or wireless network. It should be noted that sensors external to the body can also be used to monitor the muscular-skeletal system. The external sensors can be incorporated into tools or equipment and the measured data sent as disclosed above. Thus, the step 2308 of monitoring orthopedic health has been established that includes periodic quantitative parameter measurements that are used to characterize and assess muscular-skeletal status. This includes operational characteristics of any artificial implanted components.

In one embodiment, the measured data is taken periodically whereby a sufficient sample is generated to allow an analysis to be performed. In a step 2312, a data analysis is performed on the measurement data generated by the patient. The data analysis can encompass many different areas depending on the measurement data and what outcome assessment needs to reviewed. The step 2312 of data analysis can be performed with as new measured data is received. A first example of data analysis is in monitoring infection after installing an artificial joint in a patient. A patient cannot use an artificial joint immediately after surgery. The patient typically convalesces from surgery for a period of time before beginning to use the joint. A post surgical complication such as an infection can be a severe set back to rehabilitation. Infection is often a problem because the artificial surfaces of the joint are ideal areas for bacteria to multiply before the patient is aware of the problem. Common bacterial treatments may have limited effect in preventing escalation of the infection if identified after having established a strong presence in the joint region. In the limit, sepsis can occur resulting in surgical removal of the contaminated artificial joint, local treatment of the infection, and implanting a new joint.

In the step 2312, measurement in proximity of the joint region can provide information on parameters such as temperature, pH, viscosity, and other factors that are indicators of infection. The analysis is output in an electronic digital form that can be sent via the internet or other medium. The step 2312 of data analysis results in a notification of the patient status being generated. In a step 2316, a healthcare notification status is sent to the appropriate healthcare providers (e.g. physician, surgeon, hospital, clinic, etc. . . . ). Similarly, in a step 2314, a patient notification status is sent to the patient. The patient notification status can differ in content from the healthcare notification status. In one embodiment, a single status can be generated to either the healthcare providers or the patient. In a step 2320, the healthcare provider or the patient can be a notification path to the other. For example, the healthcare provider can receive a status based on the data analysis and contact the patient. One outcome is that the step 2312 yields a data analysis that no infection has been detected. The patient can continue the convalescence with regularly scheduled visits. Conversely, an outcome where the step 2312 yields the detection of an infection can result in one or more actions occurring. A step 2318, results in therapeutic treatment using the quantitative data. Early treatment of the infection can eliminate the problem. The patient can be notified in step 2318 to visit the healthcare provider and receive treatment such as antibiotics to eliminate the infection. Alternatively, the implanted device can include antibiotics or a treatment for infection local to the joint surfaces. The implanted device can be enabled to release the treatment to eliminate the infection. In either example, step 2318 results in therapeutic treatment of the infection that is continuously monitored in step 2308. Furthermore, the measurement intervals in the step 2308 can be decreased as part of the therapeutic treatment with the step 2312 of data analysis being performed when the data is received to ensure that the infection is being reduced by the treatment and verified at some point that it has been eliminated.

A second example of data analysis is in monitoring the joint kinematics after installation of an artificial joint in a patient. The patient undergoes a rehabilitation process that can include substantial physical therapy. Ideally, the patient will have increased joint mobility when compared to the degraded natural joint that was replaced. In the step 2312, measured data in proximity of the joint region can provide information on parameters such as position, relational positioning, alignment, load, and balance that are indicators of the joint kinematics. The measured data is used to assess how the joint is being used and if a potential problem should be addressed. The analysis is output in an electronic digital form that can be sent via the internet or other medium. The step 2312 of data analysis results in a notification of the patient status being generated. In a step 2316, a healthcare notification status is sent to the appropriate healthcare providers. In this example, it could be a physical therapist or physician. Similarly, in a step 2314, a patient notification status is sent to the patient. The patient notification status can differ in content from the healthcare notification status. As discussed previously, a single status can be generated either to the healthcare providers or the patient where and through a step 2320 the other is notified. One outcome is that step 2312 yields a quantitative analysis that the patient kinematics are within an acceptable range. The patient and healthcare provider can receive a notification that the artificial joint is functioning correctly. In the step 2318 a therapeutic treatment could be generated that reinforces the positive outcome by providing a program based on the quantitative data that furthers the positive outcome.

Conversely, an outcome where the data analysis step 2312 yields a potential problem results in one or more actions occurring. For example, the patient can have an issue with alignment. The data analysis would show that the alignment of the joint is incorrect using positioning and relational positioning data. This would be further corroborated by the load and balance measurements if applicable. The alignment issue could be a result of the installation or the kinematics of the patient. In either case, the result could lead to a shorter joint life span or possible catastrophic failure of the joint. A step 2318, results in therapeutic treatment using the quantitative data. A therapy could be provided based on the analysis that teaches the patient correct posture and exercises that reinforce optimal joint use. The step 2318 could also be an early correction of joint implant before it becomes a problem. The patient can be notified in step 2318 to visit the healthcare provider and receive treatment. Alternatively, the notification can include information on the issue and how to correct the issue. In either example, step 2318 results in therapeutic treatment of the issue that is continuously monitored in step 2308. Furthermore, the measurement intervals in the step 2308 can be decreased as part of the therapeutic treatment with the step 2312 of data analysis being performed when the data is received to ensure that the artificial joint kinematics are correct and or that the issue has been eliminated.

A third example of the data analysis step 2312 is in monitoring the artificial joint status. Artificial joints have a finite lifetime that is dependent on the implant installation, the implant components, and the patient lifestyle. For example, a person living a very vigorous lifestyle where the muscular-skeletal system and artificial components undergo considerable use is going to age differently from someone having a sedentary existence. A catastrophic artificial joint failure can have both physical and monetary consequences. For example, premature wear can introduce high concentration of metal and plastic particles into the patient body. The foreign material can lead to health issues. Furthermore, premature wear is an indication that the load is not being distributed correctly across a bearing surface of the joint. Typically the problem exacerbates with more wear leading to increased loading issues. This will ultimately lead to complete joint failure. The consequence of a catastrophic failure is complete replacement of the failed joint. A revision is an invasive procedure requiring each component of the artificial joint to be removed and replaced. The patient is placed under considerable stress during the procedure. Moreover, the cost burden of the replacement, which can be significant due to the complexity of the revision, is born individually or in combination with the hospital, physicians, patient, and insurance companies.

In the step 2312, measured data in proximity of the joint region can provide information on parameters such as position, relational positioning, alignment, load, and balance that are indicators of joint status. In one embodiment, the bearing surface of an artificial joint is monitored by measuring the thickness of the bearing. Wear will occur in a correctly or incorrectly operating joint. Quantitative measurement of the rate of wear and the distribution of the loading in different joint positions can provide significant information as to the joint status and operability. In general, the bearing component is replaced if the bearing surface falls below a predetermined value. The replacement of the bearing component instead of the entire artificial joint can be a much less invasive procedure thereby reducing patient stress, reducing rehabilitation time, and substantially lowering cost. The analysis is output in an electronic digital form that can be sent via the internet or other medium. The step 2312 of data analysis results in a notification of the patient status being generated. In a step 2316, a healthcare notification status is sent to the appropriate healthcare providers. In this example, it could be the patient or physician. Similarly, in a step 2314, a patient notification status is sent to the patient. The patient notification status can differ in content from the healthcare notification status. As discussed previously, a single status can be generated either to the healthcare providers or the patient where and through a step 2320 the other is notified. One outcome is that step 2312 yields a quantitative analysis that the joint status is within predetermined values. The patient and healthcare provider receive a notification that the artificial joint is functioning correctly. In the step 2318 a therapeutic treatment could be generated that further aids the patient to optimize use of the joint based on the quantitative measurements.

Conversely, an outcome where the data analysis step 2312 yields a potential problem results in one or more actions occurring. For example, the patient can have an issue with the rate of joint wear. The data analysis would show that the patient kinematics is wrong producing excessive wear or that there could be an alignment issue or material issue with the implant itself. This would be further corroborated by other parameter measurements such as load, balance, position, relational positioning and alignment measurements if applicable. In either case, the result could lead to a shorter joint life span or possible catastrophic failure of the joint. A step 2318, results in therapeutic treatment using the quantitative data. A physical therapy could be provided based on the quantitative analysis to correct how the patient is using the joint. Alternatively, the step 2318 can result in a consultation with the physician or surgeon to determine any installation or issues with the materials used to manufacture the joint. The step 2318 could result in an early correction of the joint implant before it becomes a significant problem. In either example, step 2318 results in therapeutic treatment of the issue that is continuously monitored in step 2308. Furthermore, the measurement intervals in the step 2308 can be decreased as part of the therapeutic treatment with the step 2312 of data analysis being performed when the data is received to ensure that the artificial joint kinematics are correct and or that the issue has been eliminated. A further result of the data analysis step 2312 is that the wear of the bearing is outside the predetermined range. A notification is sent to the patient and healthcare provide respectively in steps 2314 and 2316. The treatment in step 2318 is replacement of the bearing.

A fourth example of the data analysis step 2312 is in monitoring the muscular-skeletal system. In one embodiment, bone density is monitored over the patient lifecycle including prior to any bone issues and measurements taken during a surgical event. Bone density can be monitored by an external system or using one or more sensors that are implanted in bone or proximity to bone. It is well known that bone loss occurs in a large portion of the aging population by osteoporosis. The bone loss or reduction in bone strength can result in a severe injury that greatly impacts patient quality of life and adds significant cost to the healthcare system. A severe injury such as breaking a major bone of the muscular-skeletal system can result in surgery, an extended hospital visit, and a long convalescence. Moreover, it is often difficult to determine the best course of treatment for the patient or the efficacy of the approach taken. Monitoring bone health in a fashion that does not burden healthcare providers but provides clinical data on changes in bone density can have broad implications to the patient and orthopedic health in general.

In the step 2312, measured data of the bone or muscular-skeletal system is analyzed. In one embodiment, the measured data is collected over an extended period of time and in time increments that allows changes in bone density to be determined. In a non-limiting example, an acoustic signal is sent through the bone and detected after passing through a predetermined bone distance. The acoustic signal can be from an external source or be emitted and received by sensors that are placed in the bone. The time is measured for the acoustic signal to traverse the bone. The measured time corresponds to the bone density. Ideally, the time can be measured very accurately allowing for minute changes in bone density to be monitored. The quantitative measurement of the bone density and the change in bone density can provide significant information as to the health of the muscular-skeletal system. In general, bone health is a consideration if it falls below a predetermined bone density value. Similarly, bone health requires attention if a negative rate of change in bone density is detected. Addressing the issue to maintain or increase bone density brings patient and physician awareness that in combination can prevent a more severe consequence or injury. The analysis is output in an electronic digital form that can be sent via the internet or other medium. The step 2312 of data analysis results in a notification of the patient status being generated. In a step 2316, a healthcare notification status is sent to the appropriate healthcare providers. In this example, it could be the patient, physician, therapist, or muscular-skeletal expert. Similarly, in a step 2314, a patient notification status is sent to the patient. The patient notification status can differ in content from the healthcare notification status. As discussed previously, a single status can be generated either to the healthcare providers or the patient where and through a step 2320 the other is notified. One outcome is that step 2312 yields a quantitative analysis that the joint status is within predetermined values. The patient and healthcare provider receive a notification that the bone density and rate of change of bone density is normal. In the step 2318 a therapeutic treatment could be generated to incorporate supplements to maintain bone density status.

Conversely, an outcome where the data analysis step 2312 yields a potential problem results in one or more actions occurring. For example, the patient data analysis can show a significant trend in bone density loss. The data analysis provides sufficient time to address the issue before significant bone loss occurs. The bone density could be further corroborated by other parameter measurements once identified to determine cause and potential treatment. Inaction to the quantitative data analysis could result in severe health problems unless addressed in the not too distant future. A step 2318, results in therapeutic treatment using the quantitative data. A combination of supplements, medicine, and physical therapy could be suggested based on the quantitative analysis to correct bone density loss. This analysis can comprise data from a statistically significant sample having similar characteristics from the data repository and registry as well as the individual patient measured data. Alternatively, the step 2318 can result in a consultation with the physician or surgeon to further assess the measured results and design an appropriate therapy. In either example, step 2318 results in therapeutic treatment of the issue that is continuously monitored in step 2308. Furthermore, the measurement intervals in the step 2308 can be decreased as part of the therapeutic treatment with the step 2312 of data analysis being performed when the data is received to determine the efficacy of the treatment. The therapy could be adjusted in a short time span if the improvements are not adequate in slowing or preventing further bone loss. A worst-case scenario of data analysis step 2312 is that the patient bone density is outside an acceptable predetermined range or that the rate of change of bone loss is greater than a predetermined value. A notification is sent to the patient and healthcare providers respectively in steps 2314 and 2316. A diagnosis and course of treatment is then pursued in the step 2318.

FIG. 24 is a diagram 2400 illustrating a customer selection of data from a data repository and registry 2412 in accordance with at least one exemplary embodiment. There is significant value in creating a large database of parameter measurements of the muscular-skeletal system of patients. The parameter measurements characterize the muscular-skeletal system and comprise such measurements as temperature, pH, distance, weight, strain, pressure, force, balance, alignment, position, relational positioning, wear, vibration, viscosity, and density. The measurements can be taken on the natural muscular-skeletal system or artificial components used to replace portions of the system. As discussed herein, the measurements equally apply to natural and artificial components that comprise a muscular-skeletal system. In general, parameter measurements are made on patients over an extended period of time to generate useful data on the muscular-skeletal system that encompasses the aging process and orthopedic reconstruction.

In one embodiment, the parameter measurements of the sensing steps are taken with a tool, equipment, or implanted device incorporating one or more sensors for measuring parameters of the muscular-skeletal system. The tool, equipment, or implanted device converts measured parameters to an electronic digital form. In one example, the tool, equipment or implanted device is in communication with a processing unit. The processing unit can be in proximity to the tool, equipment, or implanted device for wired or wireless communication. The processing unit receives measured parameters. The processing unit can include a screen for displaying measured parameters in real time. The processing unit can be coupled to data repository and registry 2412 through a medium such as a wireless network or the internet. The data repository and registry 2412 receives, reviews, and stores the parameter measurements from the processing unit. In general, the data repository and registry 2412 is receiving parameter measurements of the muscular-skeletal from patients, healthcare providers, and other entities thereby creating a data repository of quantitative orthopedic measurements.

As disclosed hereinabove, significant data can be generated by the adoption of sensor technology that measures parameters of the muscular-skeletal system. The sensor technology has a small form factor allowing it to be integrated into different tools, equipment, and in orthopedic implants. The sensors are power efficient allowing temporary powering for on demand measurement or periodic measurement over a longer time period. In one embodiment, the sensor is a disposable item measuring such parameters as alignment, position, relational positioning, load, and balance during orthopedic joint implant surgery. Data collection of measured parameters is semi or fully automated requiring little human interaction thereby making the process transparent to the user of the tool or equipment. In one embodiment, the measured parameter data in the data repository and registry 2412 encompasses an orthopedic patient lifecycle comprising pre-operative sensing 2404, intra-operative dynamic sensing 2406, post-operative dynamic sensing 2408, and long-term dynamic sensing 2410.

Pre-operative sensing 2404 comprises parameter measurements prior to any surgery that modifies the muscular-skeletal system or introduces artificial components to the patient muscular-skeletal system. Intra-operative dynamic sensing 2406 comprises parameter measurements during surgery. The data generated can include parameter measurements that characterize component installation or modification to the muscular-skeletal system. Post-operative dynamic sensing 2408 comprises a time period where parameters are measured in proximity to the surgery. Typically, the patient convalesces from the wounds incurred by the surgery. The patient then undergoes rehabilitation of the repaired or reconstructed muscular-skeletal system. The parameters measured during post-operative dynamic sensing 2408 comprises parameters that characterize pain, infection, and muscular-skeletal status. Long-term dynamic sensing 2410 can provide measured data pertaining to patient orthopedic health and joint status. Patient orthopedic health can comprise measurements related to muscular-skeletal health, bone health, and joint kinematics. Parameter measurements can be taken on natural and artificial components to provide a status. For example, joint wear can be monitored to select an optimal time to replace a bearing surface of the joint whereby the patient undergoes a minimal invasive procedure. Patient outcomes can be analyzed using muscular-skeletal parameter measurements collected at different points in time as well as incorporating other relevant information stored in data repository and registry 2412. In one embodiment, measured data from patients can provide clinical evidence to support best in class approaches to orthopedic healthcare.

There are a number of different entities and people that can comprise customer 2402. In one embodiment, customer 2402 can access measured parameter data of the muscular-skeletal system through a website managed by the provider of data repository and registry 2412. In general, the provider of data repository and registry 2412 can provide raw data, organized data, data analysis, and other services related to measurement data of the muscular-skeletal system. For example, customer 2402 can be a government, educational facility, clinic, foundation, orthopedic manufacturer, physician, scientist, insurance company, or a patient. The measurement data can be anonymous or can include patient information. It should be noted that the measurement data, personal information, and medical histories are maintained under very strict security. In a non-limiting example, specific information related to a patient, a physician, a surgeon, a hospital, or an orthopedic manufacturer are maintained in a secure environment including safeguards to prevent access to this information unless a user can be verified having the rights to access the data. In one embodiment, the measured parameter data and private information is provided through a secure channel to a client system under control or custody of customer 2402. Alternatively, if the measured parameter data and information is of an anonymous nature it can be encrypted and sent to customer 2402 through a medium such as the internet. An example of access to private information is a patient as customer 2402 that is given access to personal, medical, and measurement data on their muscular-skeletal system. Similarly, a physician as customer 2402 can be granted access to personal, medical, and measured data of direct patients. Similarly, an orthopedic manufacturer could be given access to information and measured data related to a specific model of orthopedic implant that they sell to the market.

Customer 2402 is provided a data selection criteria 2414. As disclosed herein, data selection criteria 2414 can be displayed on a website accessible to customer 2402. In general, the website displays information of an electronic digital form that is related to the measured parameters of the muscular-skeletal system of one or more patients. Data selection criteria 2414 is used by customer 2402 to select what data in data repository and registry 2412 best suits their needs. In a non-limiting example, the data selection criteria 2414 can include parameters of the muscular-skeletal system that were measured through pre-operative sensing 2404, intra-operative dynamic sensing 2406, post-operative dynamic sensing 2408, and long-term dynamic sensing 2410. The data selection criteria 2414 can further identify an area of interest by muscular-skeletal region, orthopedic joint, measured parameter (e.g. bone density, load, distance, alignment, etc.), location, medical information, personal information (e.g. gender, age, ethnicity, etc.), and other related areas. Customer 2402 is not granted immediate access to measured data of the muscular-skeletal system but is typically vetted by the provider first. In one embodiment, customer 2402 cannot actually access the data repository and registry 2412. Access is limited to prevent data corruption, maintain security and ensure privacy of privileged information. A data request is made by customer 2402 in a step 2416. The selected quantitative parameter measurement data 2418 is retrieved or generated from data repository and registry 2412 if access is granted. The file is in an electronic digital form that can be sent through a medium to customer 2402. The generated file of measured data corresponds to the data selection criteria 2414 previously selected by customer 2402. The data request 2416 can also include an analysis of the measured data. The quantitative parameter measurement data 2418 is then sent to customer 2402. A notification can be sent to customer 2402 if it is determined that the data request includes quantitative parameter measurement data or information that is outside the approved scope of data selection criteria 2414. The customer 2402 can then modify their data request to within an approved scope and resubmit. In a further embodiment, the quantitative parameter measurement data could be periodically updated or as a significant amount of data is collected. It is expected that the amount of data being generated will become quite substantial as the sensors become ubiquitous in tools, equipment, and orthopedic implants.

FIG. 25 is a diagram 2500 illustrating intra-operative measurement of a parameter of the muscular-skeletal system in accordance with at least one exemplary embodiment. In general, an intra-operative procedure is performed in an operating room 2504 of a hospital, clinic, or healthcare facility. Operating room 2504 is a sterile environment where surgery can be performed. In one embodiment, an intra-operative orthopedic procedure exposes a portion of the muscular-skeletal system. One or more parameter measurements are taken in real-time during the procedure providing quantitative data to the surgeon or healthcare worker for assessment, modification, or reconstruction of the muscular-skeletal system. Sensored tools or equipment can be used to take measurement of the muscular-skeletal system. Sensors can also be permanently or temporarily implanted into the muscular-skeletal system for intra-operative sensing during the procedure. The measurements comprise parameters such as temperature, pH, distance, weight, strain, pressure, force, balance, alignment, position, relational positioning, wear, vibration, viscosity, and density. The parameter measurements can be taken on natural components of the muscular-skeletal system or artificial components used in the modification or reconstruction of the muscular-skeletal system to quantitatively characterize the orthopedic procedure performed. For example real time parameter measurements of load, balance, and alignment at different points in the range of motion is used by the surgeon during a joint reconstruction to optimally fit the components. These measurements can be taken in real-time with the joint in different positions throughout the range of motion using a sensored tool such as the dynamic distractor disclosed herein. Furthermore, having measurement data of the final installation provides a quantitative snapshot of the joint as it was installed by the surgeon. Implanted sensors can provide information on the muscular-skeletal status intra-operatively and post-operatively.

In general, customer 2502 can be a person or entity that accesses data repository and registry 2536 for parameter measurements of the muscular-skeletal system. In one embodiment, customer 2502 is a healthcare provider, institution, clinic, hospital, or entity that has an operating room 2504 used for orthopedic surgery. A provider of data repository and registry 2536 can provide sensors, provide information, collect quantitative measurement data, and generate reports 2520 on each orthopedic procedure performed in operating room 2504. The sensor used to measure parameters of the muscular-skeletal system can be disposable sensors that couple to equipment or tools during the procedure. The sensors are disposed of as biological waste after the procedure is completed.

In a step 2506, a surgeon performs an orthopedic procedure in operating room 2504. Typically, an orthopedic procedure performed in an operating room requires an incision to expose or provide access to a portion of the muscular-skeletal system. A sensored tool, sensored equipment, or implantable sensor is used to measure a parameter of the muscular-skeletal system in a step 2508. Real-time sensor data is generated during the procedure on one or more parameters. In one embodiment, the sensor measurements are used by the surgeon to provide quantitative measurement of the muscular-skeletal system, measurement on the repair or reconstruction of the muscular-skeletal system, or measurement on an installation of components.

The sensor converts the measured parameter into an electronic digital form that is sent to a processing unit coupled to a screen in operating room 2504. The processing unit receives the data from the sensor. The sensor can be wired, wirelessly, magnetically, or optically coupled to the processing unit. The processing unit can be local to the sensor or be remote to the sensor. The processing unit can display the data or process the data to provide a graphical representation of the measurements. The screen or display can be placed outside the surgical area but within the operating room where it can be viewed by the surgical team. The processing unit can provide a GUI on the screen. Furthermore, patient information can be entered in a step 2530. Procedure information can also be entered in a step 2532. Measured data from data repository and registry 2536 can also be received for use during the procedure. The patient and procedure information is typically entered prior to the procedure and converted to an electronic digital form. The procedure information can include the equipment, supplies, or components used during the procedure. The equipment, supplies, and component information can be scanned in or manually entered to the processing unit. Alternatively, the equipment, supplies, or components can be in communication with the processing unit to provide the information automatically prior to the procedure. The patient information, procedure information, and measured data from data repository and registry 2536 is sent to the processing unit. In a step 2534, measured data is displayed in some form on the screen. Patient information, procedure information, and measured data from data repository and registry 2536 can also be displayed on the screen with the real-time parameter measurements. Thus, the surgeon is provided measured data and information that is used to produce more consistent results and better outcomes.

In one embodiment, measurements are taken under user control. For example, a surgeon has fitted an artificial component into the muscular-skeletal system. A sensor is selected to measure a parameter that relates to the artificial component. The surgeon or member of the surgical team selects a dynamic sensor measurement in a step 2510. The one or more parameters are measured intra-operatively and then stored in memory in a step 2512. The memory can be local to the sensor or processing unit. The intra-operative measurements can also be automated to be stored periodically or at different identified points in the procedure. The process of taking measurements can occur throughout the procedure. Multiple revisions to the muscular-skeletal system can be made during the procedure. Each revision can change the outcome of the procedure. In a step 2516, measurements can be selected and stored after each revision or modification thereby providing information on the changes that were made. Final parameter measurements are selected and stored that are indicative of the completed procedure in a step 2518. The pre-final parameter measurements, final parameter measurements, patient information, and procedure information can be combined into a single file or sent as separate files. The measured data and information is sent to data repository and registry 2536 upon completion of the procedure or when a communication path between the processing unit and data repository and registry 2536 is open. The communication path can be through a medium such as a network or the internet. The measured data and information in an electronic digital form once received by data repository and registry 2536 can then be checked, formatted, and stored in the database.

One bottleneck for hospitals, clinics, and other medical institutions is in generating the paperwork that appropriately documents the procedure in operating room 2504. The documentation process takes significant time and resources that introduce cost and delay into the system. Moreover, the documentation typically does not include any quantitative measurements to the reports. In a step 2520, the measurement system generates reports that improve documentation accuracy, reduce worker time per document, and increase the efficiency of operating room 2504. In a non-limiting example, four reports are generated after the procedure is completed in step 2518. As shown a PQRI report 2522, a billing system report 2524, a purchasing system report 2526, and a clinical system report 2528 are generated in step 2520. Each form is in electronic digital form. Relevant patient information and procedure information acquired prior to the procedure are incorporated into each report.

PQRI report 2522 is a physician quality reporting system report that is related to Medicare. PQRI report 2522 has monetary implications to the surgical team and the entity responsible for operating room 2512. In general, PQRI report 2522 includes quality measures related to a service fee schedule. The goal of PQRI report 2522 is to improve the quality and lower the cost of the procedures or processes being monitored. Similarly, the clinical system report 2518 includes information on the clinical aspects of the procedure. The clinical system report 2518 is typically used by the entity responsible for operating room 2512. In general, these reports are often based on qualitative or subjective descriptions, which by its nature requires substantial input from the surgeon or surgical team. In step 2520, PQRI report 2522 and clinical system report 2518 incorporate the quantitative measurements taken during the procedure that can clinically characterize the orthopedic surgery. The surgeon or surgical team member's documentation work is reduced to adding qualitative or subjective material that supplement the quantitative measurements. In one embodiment, the documentation of the quantitative measurements can be sufficient for reporting the orthopedic procedure. Thus, the quality of the reports is improved while reducing the time required to generate the report.

The billing system report 2524 and the purchasing system report 2526 are related. In general, the billing system and purchasing systems of an entity are often two separate paths within the entity responsible for operating room 2504. Billing and purchasing information is generated in electronic digital form as part of the procedure information in step 2532. The entity (e.g. hospital, clinic, healthcare facility) wants to inventory as few components as possible that are used in orthopedic procedures. In general, the components are delivered by the manufacturer and purchased in operating room 2504. The entity responsible for operating room 2504 submits a bill for services and components to an appropriate payee of the procedure such as an insurance company or the patient. The bill typically includes the components purchased in operating room 2504. In one embodiment, the sensing system includes a reader or scanning device that retrieves information from equipment and components. In one embodiment the reader is coupled to the processing unit to store the information with the measured data. The retrieved information can include component and equipment descriptions, serial/identification numbers, and manufacturing information. Alternatively, the equipment and components used during the procedure can automatically provide the information to the processing unit when a communication path is established. For example, the sensors used for the dynamic parameter measurements can provide sensor description, identification information, and manufacturing information for use in generating the billing system report 2504 and the purchasing system report 2526 when initially communicating with the processing unit. A portion of the measured data can also be incorporated in the billing system report 2524 and purchasing system report 2526 as verification that the equipment or components were used during the procedure. In one embodiment, the step of generating reports 2520 uses the processing unit of the system that receives quantitative measurement data as a hub for also receiving the patient and procedure information. The reports are generated from the data and information gathered during the procedure. The reports can be reviewed and approved by responsible parties electronically and sent in an electronic form to appropriate entities for processing. The benefit is an efficient process that uses less resources that can rapidly generate the reports from a single data source.

FIG. 26 is a diagram 2600 illustrating one or more predetermined ranges for optimizing an outcome of an orthopedic procedure in accordance with at least one exemplary embodiment. In one embodiment, an orthopedic procedure is performed in a step 2602. In one embodiment, an orthopedic procedure occurs in a sterile environment such as an operating room but is not limited to an invasive procedure. The orthopedic procedure can be facilitated by providing the healthcare provider with sensors 2608 that generate quantitative data that aids in the procedure and can characterize the procedure. An example to illustrate how an orthopedic procedure is facilitated is reconstructive orthopedic surgery such as a joint replacement. Quantitative measurements can be taken throughout the procedure using a device such as a dynamic distractor as disclosed herein. The types of measurements required to characterize a procedure is variable and dependent on the specific procedure being performed. In the joint replacement example, the surgeon extensively modifies bone and bone surfaces to receive artificial components. Intra-operative measurements are taken with sensors 2608 during the reconstruction in a step 2606 to aid the surgeon in the installation thereby increasing the probability of a positive outcome. Sensors measuring load 2610, relational positioning 2612, alignment 2614, balance 2616, and distance 2618 are examples of measurements that solely or in combination can characterize the reconstructive procedure, provide quantitative data on the initial conditions of the installation, and increase the likelihood of a positive outcome. Measurements of load 2610, relational positioning 2612, alignment 2614, balance 2616, and distance 2618 are merely exemplary in nature.

In one embodiment, real-time intra-operative parameter measurements are displayed on a screen in step 2606. Included with the patient parameter measurements are clinical data 2624 and analysis related to the procedure and the parameters being measured. The clinical data 2624 can be stored in local memory coupled to the processing unit of the sensor system. Furthermore, the processing unit can couple to data repository and registry 2626 to download clinical data 2624 for a procedure or to update the data. Clinical data 2624 in conjunction with the subjective skill of the surgeon are used to optimize the specific procedure based on best known practices and clinical evidence. For example, predetermined ranges for the measured parameters such as load 2610, relational positioning 2612, alignment 2614, balance 2616, and distance 2618 are provided as targets for the procedure. The predetermined ranges are generated from an analysis of measured data from data repository and registry 2626 from similar procedures where the clinical evidence indicates that the probability of a negative outcome will substantially increase outside the predetermined range. Post-operative measured data and outcomes are collected as long term data 2628. Implanted sensors or sensored equipment are used to collect long-term data. The long-term data is used to monitor patient orthopedic health and to affect changes early before a major problem occurs. Long term data 2628 is sent to and part of measured patient data in data repository and registry 2626.

As mentioned above, intra-operative measurements are made throughout the procedure in a step 2604. In one embodiment, sensors 2608, a processing unit, and display are coupled together to provide the quantitative measurements to the surgeon and surgical team in the operating room. The measured parameters are compared to predetermined ranges based on clinical evidence. Real-time parameter measurement allows the surgeon to see the effect of a change or modification to the parameter. Pre-final measurements can be stored and sent to data repository 2626 under user control or through an automated process. The pre-final measurements can provide measurement data at different times prior to the procedure being completed. It should be noted that the data analysis can also provide a specific procedure sequence to minimize the effect of subsequent steps changing measured parameters that are within the predetermined range.

In one embodiment, the surgeon performs the procedure such that the measured parameters such as load 2610, relational positioning 2612, alignment 2614, balance 2616, and distance 2618 are within the predetermined ranges. The surgeon has the ability to override the use of the predetermined ranges based on the unique situation being presented. The measurement process continues providing quantitative feedback to the surgeon until the procedure is completed or the parameter measurement is no longer required. Upon completion of the procedure, the surgeon can store one or more parameter measurements that are indicative of the orthopedic procedure in a step 2622. Alignment is an example illustrating the use of predetermined ranges. An alignment measurement to a mechanical axis can show how the muscular-skeletal system is aligned to the ideal. The surgeon can modify or prepare the muscular-skeletal system to be within the predetermined alignment range when the artificial components are fitted. An analysis using clinical data 2624 in data repository and registry 2626 had determined that alignment within the predetermined range increases the probability of a positive outcome. Similarly, clinical evidence of load and balance measurements within identified predetermined ranges produce an increased probability of a positive outcome. Position and relational positioning measurements provide three dimensional information on how one or more components of the muscular-skeletal system are oriented. The positional measurements can be used in conjunction with other parameter measurements to show changes over a range of motion. Thus, an initial condition of the resulting procedure is provided to the data repository and registry 2626 that can be compared with long term data 2638 taken on the patient muscular-skeletal system over an extended period of time.

It is well known that partial and total joint reconstructions number in the millions of procedures per year. This is only a portion of the total orthopedic procedures being performed. The revision rate is unacceptably high for some reconstructive procedures often occurring in double digit percentages. It is beneficial from a cost, time, and patient perspective to reduce post-operative complications. In general, a process to create a substantial portfolio of quantitative data is generated by providing evidentiary based feedback to customers. The evidentiary based feedback improves outcomes and reduces revisions thereby increasing operating room efficiency, increasing profitability, and lowering cost. In one example, customers are the entities that manage operating rooms and the people that use the operating rooms. Examples of customers are hospitals, clinics, healthcare providers, and research institutions. The users of operating rooms are typically physicians, surgeons, and surgical support staff.

In one embodiment, the provider of data repository and registry 2625 also can provide sensors in a step 2604 that measure parameters of the muscular-skeletal system directed towards improving orthopedic outcomes. The intra-operative sensors can be low cost disposable devices that promote use and acceptance of sensing technology for orthopedics. In one example, disposable sensors used intra-operatively are rendered inoperative in a step 2630. It is likely that that sensors used intra-operatively have been exposed and contaminated with biological material. The disposable sensors are then disposed of after step 2632 when the procedure has been completed so they cannot be used again.

Operating rooms that use the sensor system will provide a continuous flow of quantitative measurements to data repository and registry 2626 with each orthopedic procedure. Similarly, the use of implanted sensors or sensing equipment to monitor the procedure status will generate long term data 2628. Both the intra-operative and other measurements (including post-operative) are converted to an electronic digital form, sent through a medium such as a wireless network or the internet, and then stored in data repository and registry 2626. The provider of data repository and registry 2626 provides analyses using the quantitative measurements. The analysis will rise to a level of a clinical study when a statistically significant sample is provided from data repository and registry 2626. In one embodiment, the analysis will support an evidentiary based outcome with clinical evidence from data repository and registry 2626. The benefit of the analysis is further discussed for the orthopedic joint repair or reconstruction where an alignment to a mechanical axis of the muscular-skeletal system can be critical to optimize the joint mechanics. Misalignment of the joint to the mechanical axis can result in premature wear that reduces longevity of the joint (natural or artificial) and in the limit catastrophic failure of the joint. Analysis of intra-operative and post-operative quantitative measurements in data repository and registry 2626 can determine that negative outcomes can be reduced substantially by aligning the repaired or reconstructed joint within a predetermined range of alignment to the mechanical axis. As discussed above, the alignment predetermined range is provided to the client and is displayed on the sensor system screen. The surgeon then uses the sensor system to measure misalignment to a mechanical axis and to make adjustments to ensure that the misalignment does not exceed the predetermined range based on the clinical evidence. The feedback path is continuous with the data from surgeries using the predetermined range being incorporated into data repository and registry 2626. Thus, a system of data generation and results oriented feedback is created that hones in on an optimal orthopedic procedure. This approach is similarly applied to long-term data 2628 on providing evidentiary based processes or treatments to areas such as infection, pain management, rehabilitation, kinematics, and bone health.

FIG. 27 is a diagram 2700 illustrating health risk identification and notification an orthopedic device, procedure, or medicine in accordance with at least one exemplary embodiment. An entity 2702 typically comprises an individual, organization, institution, government, or business having an interest in measured parameters of the muscular-skeletal system. At this time, it is difficult to identify potential health risks to patients due to an orthopedic device, procedure, or medicine. An orthopedic device can include equipment, tools, orthopedic implants, orthopedic components, materials, and other devices used to heal, repair, or reconstruct the muscular-skeletal system. At issue is the fact that little or no patient muscular-skeletal measurements are taken and documentation linking specific devices, patient information, medical information, and procedure information resides in a wide variety of locations and in different formats. A health risk 2716 is typically determined by an analysis over an extended period of time and the data collected must rise to a standard that clinically proves the existence and source of the problem. Ideally, the issue is identified early to provide a solution that minimizes patient risk.

As described hereinabove, a path is provided for collecting and storing muscular-skeletal parameter measurements. Small form factor sensors are incorporated in tools, equipment, artificial implants, or implanted in the muscular-skeletal system to allow measurement over an extended period of time. The sensors sense parameters such as temperature, pH, distance, weight, strain, pressure, force, balance, alignment, position, relational positioning, wear, vibration, viscosity, and density. Measurements can be taken periodically or under user control to monitor status of the muscular-skeletal system. The measured parameters and information are converted to an electronic digital form. The sensor or sensor systems are in communication with data repository and registry 2720. The parameter measurements are sent as the measurements occur or stored temporarily until a communication path such as a wireless network or the internet is available. Patient personal information, medical information, procedure information, and device information can also be collected with the parameter measurements and stored in data repository and registry 2720. Thus, data repository and registry 2720 is a hub where quantitative measured data and information exists in a single location for an analysis with supporting clinical evidence. This provides the additional benefit where patients at risk can be notified in a timely fashion to address an identified issue.

As it name implies data repository and registry 2720 is a registry that links measured parameters of the muscular-skeletal system to information. In a non-limiting example, information on devices such as an artificial joint of the muscular-skeletal system can be stored in the data repository and registry 2720. The information can comprise performance specifications, manufacturing information, serial numbers, lot numbers, date of sale, and other relevant information. The information can be scanned, transmitted from the device, or entered manually. Registry 2720 provides a path to more specific manufacturing information that allows identification of devices that pose a patient risk.

In general, the data repository and registry 2720 provides quantitative data over an orthopedic life cycle of a device, procedure, or medicine from a statistically significant number of patients. An example, where generating quantitative measurements provides substantial benefit is in the repair or reconstruction of a joint of the muscular-skeletal system. Typically, a surgical procedure is performed in an operating room to repair or reconstruct the muscular-skeletal system. The procedure can modify the natural joint or surrounding muscular-skeletal system. Alternatively, a prosthesis can be implanted to replace the natural joint. The muscular-skeletal system is a mechanical system where the natural or artificial components are prone to wear. Degradation of a natural or artificial joint can be exacerbated by abnormal wear and misalignment. Similarly, degradation or failure can occur due to the installation or components. Thus, there is a need to provide measurements that can assess joint status over an extended period of time.

In one embodiment, a surgical procedure on the muscular-skeletal system of a patient provides a convergence of data and information that is collected in an operating room. Typically, a patient has gone through substantial evaluation before submitting to an orthopedic surgery. The surgeon requires an awareness of patient information, medical history, the procedure being performed, equipment, materials, and implanted components. In the example, a sensor system is used to display and store measurements of the muscular-skeletal system during the surgery as disclosed herein. The quantitative measurements taken during the surgery are used to support the surgeon's subjective skills to optimally perform the procedure. The sensor system is also a path to receive, display, and store information related to the patient (personal and medical), procedure, equipment used, materials used, and devices used. Information can be retrieved automatically, scanned in, or manual input to the sensor system. Thus, a linkage between measured data and information pertaining to the patient, procedure, and devices is initiated in the operating room that can be further linked to other collected data and information. The measured data and information is converted to a digital form and sent to data repository and registry 2720 for storage.

Quantitative measurements 2706 are stored in data repository and registry 2720. Measurements 2706 comprise pre-operative measurements 2708, intra-operative measurements 2710, post-operative measurements 2712, and long-term measurements 2714. In general, measurements 2706 comprise measurements of the muscular-skeletal system that are taken at different times. Measurements 2706 are converted to an electronic digital form and sent to data repository and registry 2720. Pre-operative measurements 2708 comprises parameter measurements prior to any surgery that modifies the muscular-skeletal system or introduces artificial components to the patient muscular-skeletal system. Intra-operative measurements 2710 comprises parameter measurements during surgery. The measured data can characterize component installation, repair, or modification to the muscular-skeletal system. Post-operative measurements 2712 are a subset of long-term measurements 2714 that occur after the surgery. Post-operative measurements 2712 comprises a time period shortly after the surgery where the patient convalesces and rehabilitates. Long-term measurements 2714 comprises quantitative data pertaining to patient orthopedic health and joint status. Patient orthopedic health can comprise measurements related to muscular-skeletal health, bone health, and joint kinematics.

In the example, pre-operative measurements 2708, post-operative measurements 2712, and long-term measurements 2714 are linked to the measured data and information gathered intra-operatively thereby creating a quantitative measurement history of a patient muscular-skeletal system. The quantitative measurements in data repository and registry will grow exponentially as operating rooms adopt sensor measurement. The use of the data and information will result in the escalation of evidence based orthopedic medicine. It should be noted that muscular-skeletal measurement or monitoring does not end after a procedure is performed. Quantitative measurements of each patient continues over an extended period of time providing further clinical evidence to identify the cause of a negative outcome.

In general, a clinical data analysis is performed in a step 2704. The analysis uses measurements 2706 from data repository and registry 2720. Pre-operative measurements 2708, intra-operative measurements 2710, post-operative measurements 2712, and long-term measurements 2714 that relate to the orthopedic device, procedure, or medicine can be accessed from data repository and registry 2720. In one embodiment, the analysis is a report that includes a statistically significant sample of measured parameters from measurements 2706 that represent clinical evidence to prove patient risk or a negative outcome related to an orthopedic device, procedure, or medicine. A determination of whether a health risk exists is made in step 2716. No action is taken in a step 2722 when no health risk is posed. An action is initiated in a step 2718 when evidence of a health risk has been determined for an orthopedic device, procedure, or medicine. A notification 2728 is then generated to at least one entity. Notification 2728 can vary in content depending on the audience and will typically be sent to more than one entity. For example, a recall can be initiated if a defective material in an artificial joint is identified in step 2704 that could produce catastrophic failure of the device or pose long term health risks. Information relating to a device, procedure, or medicine such as the recalled artificial joint can be retrieved from data repository and registry 2720 in a step 2724. The device, procedure, or medicine information can be incorporated in notification 2728. Similarly, patients having the recalled artificial joint can be identified in a step 2726 and incorporated in notification 2728. In one embodiment, notification 2728 is sent in electronic digital form to an appropriate entity such as a patient, manufacturer, government, media, or healthcare provider. Thus, data repository and registry 2720 can be used to provide clinical evidence of a health risk to patients and to rapidly notify a large number of people and entities spread over wide geographic areas.

FIG. 28 is a diagram 2800 illustrating an analysis of the efficacy of an orthopedic device, procedure, or medicine in accordance with at least one exemplary embodiment. An entity 2802 typically comprises an individual, organization, institution, government, or business having an interest in measured parameters of the muscular-skeletal system. A data repository and registry 2818 comprises pre-operative measurements 2810, intra-operative measurements, 2812, post-operative measurements 2814, and long term measurements 2816 for the orthopedic device, procedure, or medicine. The measured parameters quantitatively characterize the device, procedure, or medicine. The measurements are taken on a statistically significant number of patients that can be used as clinical evidence to the efficacy of a device, procedure, or medicine. In one embodiment, sensors are used to sense parameters such as temperature, pH, distance, weight, strain, pressure, force, balance, alignment, position, relational positioning, wear, vibration, viscosity, and density. The measured parameters and information from the sensors are converted to an electronic digital form and are sent through a medium such as the internet to data repository and registry 2818.

The sensors or sensored equipment that are used to take measurements can be automatic or under user control. Measurements are taken at different points in time corresponding to pre-operative measurements 2810, intra-operative measurements, 2812, post-operative measurements 2814, and long term measurements 2816. In general, information is collected and stored in data repository and registry 2818 with the measurements. In one embodiment, patient information, equipment information, procedure information, or component information is collected in an operating room prior to and during an orthopedic procedure. The surgeon can access and use the information during the procedure. The information and intra-operatively measured parameters are converted to an electronic digital format and sent to data repository and registry 2818. The collection of information can occur prior to and during the procedure. The information can be collected at different times, stored, incorporated together, and sent to repository and registry 2818 by the sensored equipment.

In general, the data repository and registry 2818 provides quantitative data over an orthopedic life cycle of a device, procedure, or medicine from a statistically significant number of patients. The sensors or sensor systems are deployed at a variety of locations such as physician offices, clinics, hospitals, healthcare provider facilities and patient homes to facilitate the creation of a large sample of quantitative data. An example, where generating quantitative measurements provides substantial benefit is in a measurement of bone density of the muscular-skeletal system. A degenerative bone disease such as osteoporosis is a growing problem worldwide. A loss of bone density can weaken the bone thereby increasing the probability of injury. A severe bone injury can be life threatening to an elderly person. There is also substantial cost associated with this type of injury that may include surgery, an extended hospital stay, and therapy. In the example, different sensors or sensored equipment is used to monitor the muscular-skeletal system over an extended time period. Measurements on one or more parameters related to bone health are taken on a large group of patients. In one embodiment, one or more bones are monitored for changes in bone density. The change in bone density can be positive or negative. The measurements and any collected information are converted to a digital form by the sensor or sensored system and sent through a medium such as the internet to data repository and registry 2818.

In the non-limiting example, treatment for bone loss can take the form of a device, procedure, or medicine. For example, a device that stimulates bone growth can be used by a patient. Similarly, a procedure could be performed to affect bone strength or to strengthen a weakened area. Finally, a medicine, drug, supplement, or other remedy could be administered to treat the bone loss. In each methodology for treating bone loss the sensor or sensor system provides quantitative measurement of bone health, bone density, or bone strength over time. The sensor system can include a processing unit that can receive, process, and display measured data and information. In one embodiment, information related to the patient (personal and medical), procedure, equipment, materials, medicines, and devices is available with the measured data. Information can be retrieved automatically, scanned in, or manual input to the sensor system. Thus, a linkage between measured data and information pertaining to the patient, procedure, and devices is stored that can be further linked to other collected data and information. The measured data and information is converted to a digital form and sent to data repository and registry 2818 at a centralized location for efficacy studies.

Pre-operative measurements 2810 comprises parameter measurements prior to any surgery that modifies the muscular-skeletal system or introduces artificial components to the patient muscular-skeletal system. Intra-operative measurements 2812 comprises parameter measurements taken during surgery. The measured data can characterize component installation, repair, or modification to the muscular-skeletal system. Post-operative measurements 2814 are a subset of long-term measurements 2816 that occur after the surgery. Post-operative measurements 2814 comprises a time period shortly after the surgery where the patient convalesces and rehabilitates. Long-term measurements 2816 comprises quantitative data pertaining to patient orthopedic health and joint status. Patient orthopedic health can comprise measurements related to muscular-skeletal health, bone health, and joint kinematics. It should be noted that any devices, procedures, and medicines used by the patient can have singular or combinatorial effects to an outcome that is captured in the measurements stored in data repository and registry 2818.

An analysis of the efficacy of a device, procedure, or medicine is performed in a step 2804. The analysis uses measurements 2808 from data repository and registry 2818 comprising pre-operative measurements 2810, intra-operative measurements 2812, post-operative measurements 2814, and long-term measurements 2716 that relate to the orthopedic device, procedure, or medicine. In one embodiment, the quantitative measurements represent clinical evidence of the efficacy of the orthopedic device, procedure, or medicine. In the example of bone loss, the quantitative measurements would show the change in bone density due to the device, procedure, medicine, or a combination thereof. The amount of change in maintaining bone health would determine the efficacy. A cost analysis can be performed in a step 2806. The cost analysis links the efficacy analysis with the cost of producing a positive outcome. In the bone loss example, a cost analysis can conclude that a device, procedure, or medicine provides a similar result in the comparison but one has substantially lower cost. Conversely, the cost analysis can show that a higher cost solution provides substantially better outcomes. The higher cost solution may by itself be acceptable based on the efficacy. The higher cost of the solution could also be mitigated by the reduction in the number of catastrophic bone failures that result in surgery, hospital stays, and rehabilitation that greatly increase cost.

It is well known that the high cost of healthcare is an issue for patients, the government, healthcare providers, and businesses. It would be of substantial value to provide a path to efficiently evaluate different methodologies that address an orthopedic outcome. In general, it is desired to promote and utilize solutions that provide the best outcome at the lowest cost. For example, the government and insurance companies are faced with an increasing number of orthopedic joint reconstructions at substantial cost. Many of these joint reconstructions have a finite lifetime and may have to replaced within the patients lifetime. A further issue is that there is a high rate of revision and post-operative issues due to a number of factors that includes the subjective nature of the surgery. A comparison of the efficacy and cost of different solutions can be monitored by entity 2802. A change may be indicated after the analysis in steps 2804 and 2806. The criteria for the change is a function of cost versus efficacy or a combination thereof. The change factors can be provided by entity 2802 and incorporated in the analysis. If the analysis yields that no change is required than no action is taken in a step 2822. In one embodiment, the analysis is performed by the provider of data repository and registry 2818.

A notification 2826 is generated that is sent to at least one entity when a change is identified in step 2820. Notification 2728 can vary in content depending on the audience and will typically be sent to more than one entity. For example, notification 2826 can be generated to notify patients that there is a preferred solution based on clinical evidence from data repository and registry 2818. In one embodiment, data repository and registry 2818 is used to optimize patient health and lower health care cost. In a step 2824, a cost modification can be the result of the analysis. For example, a cost modification can be an allowed amount of reimbursement for a particular solution. The reimbursement can be directed to patients, physicians, healthcare providers, hospitals, clinics, manufacturers, pharmacological companies, and other entities related to the orthopedic industry. The amount of reimbursement based on clinical evidence can have a substantial impact on lowering healthcare costs. Information on the cost modification or measured data relating to a device, procedure, or medicine can be provided from data repository and registry 2818 in electronic digital form and incorporated into notification 2826. Thus, data repository and registry 2818 can be used to provide clinical evidence that quantitatively identifies the best patient solutions while lowering healthcare costs by collecting data from a large number of people and entities spread over wide geographic areas.

In summary, the invention describes a system to define the joint gap, bone preparation, alignment, load, and balance by measurement. Furthermore the surgeon obtains the information in real time from the system while soft tissue release and alignment is being performed. The graphic user interface can be in the device itself or integrated with a processing unit and display in the operating room. The sensors can be incorporated into tools and equipment for measuring the muscular-skeletal system pre-operatively, intra-operatively, post-operatively, and long term. The sensors or sensor system is in communication with a data registry and repository to generate statistically significant data that can be used as clinical evidence. The data repository and registry further includes information used in evidentiary based orthopedic medicine. This invention while intended for use in the medical field and more specifically orthopedics uses a knee application to illustrate principles of the system and method for illustrative purposes only and can be similarly adapted for the hip, shoulder, ankle, spine, as well as to measure other parameters of a biological system.

While the present invention has been described with reference to exemplary embodiments, it is to be understood that the invention is not limited to the disclosed exemplary embodiments. The scope of the following claims is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions. 

1. A computer implemented method of notification of patient risk for an orthopedic device, procedure, or medicine comprising: performing an analysis of a statistically significant sample of measured parameters from a data repository and registry where the analysis indicates a patient risk; initiating an action if a patient risk is identified; generating a notification of patient risk; and sending at least one notification in electronic digital form to at least one entity.
 2. The method of claim 1 further including the steps of: receiving measured parameters of the muscular-skeletal system in an electronic digital form from more than one entity; and storing the measured parameters in the data repository and registry.
 3. The method of claim 2 further including the steps of: collecting at least one of patient information, equipment information, procedure information, or component information in an operating room; converting the at least one of patient information, equipment information, procedure information, component information to an electronic digital format; generating at least one intra-operatively sensed parameter measurement in the operating room; sending the at least one of patient information, equipment information, procedure information, or component information, and the at least one intra-operatively sensed parameter measurement to the data repository and registry.
 4. The method of claim 3 further including the steps of: measuring parameters of the muscular-skeletal system of the patient post-operatively to generate post-operative measurements and long term measurements; converting measured parameters of the muscular-skeletal system of the patient to an electronic digital form; and sending measured parameters of the muscular-skeletal system of the patient to the data repository and registry.
 5. The method of claim 1 further including the steps of: accessing pre-operative measurements related to the orthopedic device, procedure, or medicine from the data repository and registry; and using pre-operative measurements as clinical evidence in the analysis of patient risk due to the orthopedic device, procedure, or medicine.
 6. The method of claim 1 further including the steps of: accessing intra-operative measurements related to the orthopedic device, procedure, or medicine from the data repository and registry; and using intra-operative measurements as clinical evidence in the analysis of patient risk due to the orthopedic device, procedure, or medicine.
 7. The method of claim 4 further including the steps of: accessing post-operative measurements related to the orthopedic device, procedure, or medicine from the data repository and registry; and using intra-operatively sensed parameter measurements as clinical evidence in the analysis of patient risk due to the orthopedic device, procedure, or medicine.
 8. The method of claim 4 further including the steps of: accessing long term measurements related to the orthopedic device, procedure, or medicine from the data repository and registry; and using intra-operatively sensed parameter measurements as clinical evidence in the analysis of patient risk due to the orthopedic device, procedure, or medicine.
 9. The method of claim 1 further including a step of sending the notification to one or more manufacturers.
 10. The method of claim 1 further including a step of sending the notification to one or more patients.
 11. A computer implemented method of notification of patient risk for an orthopedic device, procedure, or medicine comprising the steps of: storing measured parameters of the muscular-skeletal system converted to an electronic digital form in a data repository and registry where the data repository and registry includes at least one of patient information, equipment information, procedure information, or component information; identifying an orthopedic negative outcome where the negative outcome is supported by clinical evidence related to the measured parameters in the data repository and registry; generating a notification in the electronic digital form; and sending the notification to at least one at least one entity.
 12. The method of claim 11 further including a step of identifying the orthopedic device, procedure, or medicine related to the negative outcome from information in the data repository and registry.
 13. The method of claim 11 further including a step of performing an analysis of a statistically significant sample of measured parameters from the data repository and registry where the analysis indicates a patient risk.
 14. The method of claim 13 further including a step of using one or more of pre-operative measurements, intra-operative measurements, post-operative measurements, and long term measurements in the analysis from data repository and registry.
 15. The method of claim 11 further including the steps of: identifying patients related to the negative outcome from information in the data repository and registry; and sending notification related to the analysis to the patients.
 16. A computer implemented method of notification of patient risk for an orthopedic implant or procedure comprising the steps of: performing an analysis of a statistically significant sample of measured parameters from a data repository and registry where the analysis indicates a patient risk from the procedure or orthopedic implant; initiating an action if a patient risk is identified; generating a notification in electronic digital form of patient risk; and sending at least one notification in electronic digital form to at least one patient.
 17. The method of claim 16 further including the steps of: identifying the orthopedic device or procedure from information in the data repository and registry; and incorporating information related to the orthopedic device or procedure in the notification.
 18. The method of claim 16 further including the steps of: identifying the patients at risk from information in the data repository and registry; and incorporating information related to the patient in the notification.
 19. The method of claim 16 further including a step of using one or more of pre-operative measurements, intra-operative measurements, post-operative measurements, and long term measurements in the analysis from data repository and registry.
 20. The method of claim 16 further including the steps of: receiving measured parameters of the muscular-skeletal system in an electronic digital form from more than one entity; and storing the measured parameters in the data repository and registry. 